Clinical Trials

ONGOING RESEARCH FOR BETTER EVIDENCE

At Abbott, we are committed to investing in clinical trials and evidence to continue building better solutions for patients worldwide and to build trust in the safety and performance of our portfolio of life-changing structural heart devices. With over 45 planned clinical trials, we take great pride in building confidence for physicians and patients.
 

This page is intended to provide clinical trial information only. The products and procedures discussed on this page are currently in clinical study and are not approved
for commercial use.

STRUCTURAL INTERVENTIONS

CATALYST Trial

CATALYST Trial

Clinical trial of atrial fibrillation patients comparing left atrial appendage occlusion therapy to non-vitamin K antagonist oral anticoagulants.


CAUTION: Amplatzer Amulet LAA Occluder is an investigational device. Limited by Federal (U.S.) law to investigational use only.

  • Eligible Patients
    • A documented history of non-valvular atrial fibrillation
    • CHA2DS2-VASc score ≥ 3
    • Eligible for long-term NOAC therapy

    The CATALYST Trial will compare treatment with Abbott's Amplatzer™ Amulet™ Left Atrial Appendage Occluder to treatment with non-vitamin K antagonist oral anticoagulants (NOACs) in patients with non-valvular atrial fibrillation at high-risk for stroke.

  • Procedure overview

    Subjects will be randomized 1:1 to receive the Amplatzer Amulet Left Atrial Appendage Occluder or NOAC therapy in the CATALYST Trial. The Amulet occluder is delivered in a minimally invasive transcatheter approach through a femoral venous puncture. The Amulet occluder is introduced to the left atrium via an interatrial transseptal puncture. The lobe secures the Amulet occluder within the left atrial appendage, while the disc completely seals the appendage at the orifice.

    1. The Amulet delivery system is introduced via femoral venous puncture and enters the right atrium.

    2. A transseptal puncture allows the Amulet delivery system to enter the left atrium.

    3. The Amulet Occluder is guided to the left atrial appendage using echocardiography and fluoroscopy. Retention wires on the lobe secure the occluder, while the disc expands to seal the appendage orifice.

  • NOAC Overview

    NOACs reduce the risk of stroke or systemic embolic events compared to warfarin.1 However, large trials comparing the safety and efficacy of NOACs vs LAAO therapy are lacking. Subjects randomized to NOAC therapy may be prescribed any commercialy available NOAC according to drug labeling and may switch between NOACs over the course of the trial if justified. Adherence to NOAC therapy is important to the trial, and should be expressed to the patient.

To learn more about the CATALYST Trial, including eligibility criteria and study locations, please visit the ClinicalTrials.gov website.

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Paravalvular leak closure with the Amplatzer Valvular Plug III occluder for interventional transcatheter closure for PVL with surgical biological and mechanical heart valve. The PARADIGM trial for patients with clinically significant paravalvular leak (PVL) who are eligible for transcatheter closure is now underway and will be studying approximately 200 subjects in up to 25 medical centers worldwide.

  • Eligible Patients
    • Has a mechanical or biological surgical valve in the aortic or mitral position
    • A documented clinically significant PVL with signs of heart failure or hemolysis

     

    The PARADIGM study will evaluate the safety and efficacy of the Amplatzer™ Valvular Plug III as a treatment for PVL following surgical implant of a mechanical or biological heart valve in the aortic or mitral position.

  • Procedure overview

    Subjects will receive the Amplatzer Valvular Plug III (AVP III) in the PARADIGM Study. The AVP III is delivered in a minimally invasive transcatheter approach. The AVP III is introduced to the closure site and the waist and discs will seal the paravalvular leak that has developed adjacent to a surgically implanted mechanical or biological heart valve.

To learn more about the PARADIGM Trial, including eligibility criteria and study locations, please visit the ClinicalTrials.gov website.

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TRANSCATHETER SOLUTIONS

The REPAIR MR Trial (Percutaneous MitraClip™ Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery) is now underway, and will be studying 500 patients at up to 60 medical centers in the United States, Canada, and Europe.

This clinical trial will study the MitraClip™ Transcatheter Mitral Valve Repair system in patients with severe primary mitral regurgitation who are at moderate surgical risk and whose mitral valve (MV) has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. The objective of this trial is to compare the clinical outcomes of the MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk.


CAUTION: MitraClip (for REPAIR MR indications) is an investigational device. Limited by Federal (U.S.) law to investigational use only.

  • Transcatheter mitral valve repair (TMVr)*

    Transcatheter mitral valve repair is a less-invasive treatment option for patients who are deemed appropriate for this procedure. The procedure is done using the MitraClip Transcatheter Mitral Valve Repair system.

    1. A guide catheter (a thin tube) will be inserted through a vein from a small cut in your upper leg to reach your heart.

    2. The MitraClip implant, which is attached to the end of a clip delivery system, will be guided to your mitral valve through the catheter.

    3. The implant will be positioned and the clip will grasp the mitral valve leaflets to close the center of the mitral valve and reduce MR.

    4. Once the clip is in place, it will be separated from the clip delivery system.

    5. The implanted clip will become a permanent part of your heart, allowing your mitral valve to close more tightly and reduce the backward flow of blood.

  • Eligibility criteria

    Key inclusion criteria

    Subjects must meet all of the following inclusion criteria in order to participate in the trial:

    • Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR as assessed by the echocardiography core-lab (mixed etiology is acceptable provided the principal mechanism of action is due to degenerative mitral valve pathology)
    • The cardiac surgeon of the site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the eligibility committee (EC) has confirmed that the subject’s mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
    • Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure > 50 mmHg, or LVESD > 40 mm
    • Subject is at least 75 years of age, OR if younger than 75 years, then has:
      • Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, or
      • Presence of other comorbidities which may introduce a potential surgery-specific impediment
    • Subject provides written informed consent
    • Subject is ≥ 18 years of age
       

    Key exclusion criteria

    Subject must not meet any of the following exclusion criteria in order to participate in the trial:

    • Subject is currently participating in another clinical investigation
    • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
    • Subject has ischemic or non-ischemic secondary MR
    • Concomitant severe tricuspid valve regurgitation
    • Ejection fraction < 30%
    • Severe mitral annular calcification
    • Acute myocardial infarction in the past 12 weeks
    • Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
    • Subjects who have concurrent coronary artery disease may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery.
    • Surgical procedure performed in the past 30 days
    • Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
    • Transesophageal echocardiography (TEE) is contraindicated
    • Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or Intra-Aortic Balloon Pump (IABP)
    • Need for emergency surgery for any reason
    • Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or Ventricular Assist Device (VAD)
    • Systolic anterior motion of the Mitral Valve
    • Hypertrophic cardiomyopathy
    • Renal insufficiency requiring dialysis
    • Active infections requiring current antibiotic therapy
    • Subjects who are pregnant or planning to be pregnant
  • Repair MR trial design

    This is a prospective, multi-center, randomized, controlled, clinical investigation of 500 subjects at 60 medical centers in the United States, Canada, and Europe.

    Clinical follow-ups will be a combination of in-person and phone only follow ups.

    Between year 2 and 10 follow ups will take place every year. 

    Clinical follow-ups will be a combination of in-person and phone only follow ups.

    Between year 2 and 10 follow ups will take place every year. 

  • Clinical trial endpoints

    Co-primary endpoint #1

    All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)

    Co-primary endpoint #2

    Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years

    Secondary endpoints

    The following secondary endpoints will be assessed and compared between device and control:

    • Proportion of subjects with MR ≤ mild (1+) at 30 days post-index procedure among survivors
    • Hospital length of stay from procedure to home discharge (days)
    • Proportion of subjects discharged to home post index hospitalization
    • Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors.
    • Severe symptomatic mitral stenosis at 1 year
  • About mitral regurgitation

    More lives are compromised by Mitral Regurgitation (MR) than any other valve disease. It is a progressive disease; if left untreated, it can lead to heart failure, or even death.2 MR is reported to have a 5-year mortality rate of 47%.3

    Guideline-Directed Medical Therapy (GDMT) can be used to treat MR in certain patients. Certain beta-blockers and renin-angiotensin-aldosterone pathway inhibitors have been associated with reverse LV remodeling.4 In some patients, GDMT has been associated with diminished MR severity.5 However, data indicate that many patients go without recommended treatment because adherence to cardiology society guidelines is poor.6-8 In addition, the outlook for patients whose severe MR persists in spite of optimal medical therapy remains bleak.9

    Open-heart surgery may be an option to have the mitral valve repaired or replaced. However, as many as half of the symptomatic patients presenting with severe MR, who meet the Class I indications of surgery, do not undergo MV surgery.10 Also, their referral is often delayed until the symptoms are too severe, which leads to sub-optimal long term outcomes. A minimally invasive treatment option that offers an acceptable benefit-risk profile for these patients is needed.

*TMVr is also referred to as TEER (transcatheter edge-to-edge repair)

To learn more about the REPAIR MR Trial, including eligibility criteria and study locations, please visit the ClinicalTrials.gov website.

LEARN MORE

SUMMIT trial examines transcatheter mitral valve replacement (TMVR) with Tendyne™ mitral valve

The SUMMIT Trial (Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation) is now underway, and will be enrolling patients at up to 80 sites in the U.S., Canada, Europe, and Japan.1

The trial is examining a treatment with the Tendyne Transcatheter Mitral Valve System, for patients who have symptomatic, moderate-to-severe or severe mitral regurgitation (MR) or mitral annular calcification (MAC) and who are appropriate candidates for TMVR. The objective of this trial is to:

  • Determine whether this technology improves clinical outcomes for the large number of patients suffering from the debilitating symptoms of moderate-to-severe or severe MR
  • Compare the TMVR outcomes to MitraClip™ transcatheter mitral valve repair, the standard of care for patients not suitable for mitral valve surgery.


CAUTION: Tendyne is an investigational device. Limited by Federal (U.S.) law to investigational use only.

  • Tendyne transcatheter mitral valve replacement (TMVR)

    The Tendyne Transcatheter Mitral Valve is a bioprosthesis designed to reduce MR and improve blood flow through the heart. The following steps provide a general overview of the Tendyne procedure.

    1. Access to the heart is gained through a small incision in the chest between the ribs.


    2. The Tendyne valve is placed in the heart through a catheter.


    3. The tether is secured to a pad at the bottom of the heart. The valve, tether, and pad are designed to become a permanant implant, reduce MR, and improve blood flow.

    The Tendyne valve is a uniquely designed device consisting of:

    • A dual frame valve contoured to fit the natural shape of the native anatomy
    • A tether connecting to an integrated apical pad that supports valve securement and is placed over the apical access site
  • Eligibility criteria
    • Symptomatic, moderate-to-severe or severe MR of any etiology (primary, secondary, or mixed) or severe MAC
    • NYHA Class ≥ II (if Class IV, patients must be ambulatory)
    • Determination by the site’s heart team that the subject has been adequately treated for coronary artery disease (eg, revascularization), left ventricular (LV) dysfunction (eg, cardiac resynchronization therapy), and heart failure (eg, guideline-directed medical therapy)


    Randomized cohort eligibility limited to:

    • Patients suitable for TMVR with Tendyne and indicated for transcatheter mitral valve repair with MitraClip


    Non-repairable cohort eligibility limited to:

    • Subjects who are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair


    MAC cohort eligibility limited to:

    • Patients who have severe MAC resulting in symptomatic mitral valve disease (MR ≥ Grade III, or severe mitral stenosis [MS], or both moderate MR and moderate MS) rendering the subject unsuitable for mitral valve surgery
  • SUMMIT trial design

    This is a prospective, controlled, multi-center clinical investigation. Investigators anticipate a 48-month recruitment period, with subject follow-up continuing for an additional 60 months.

    *2017 ASE Guidelines.
    Associated with MR ≥ Grade III, severe MS, or moderate MR with moderate MS.

    *2017 ASE Guidelines.
    Associated with MR ≥ Grade III, severe MS, or moderate MR with moderate MS.

  • Study endpoints

    MVARC = Mitral Valve Academic Research Consortium.

    MVARC = Mitral Valve Academic Research Consortium.

  • About mitral regurgitation

    A progressive disease, MR initiates a cascade of events progressing to heart failure, then death, if left untreated.4 The 1-year mortality of MR can be as high as 57%.5

    Certain medical therapies, such as beta-blockers and renin-angiotensin-aldosterone pathway inhibitors, have been associated with reverse LV remodeling.6 In  some cases, they have been associated with diminished MR severity.7 However, data indicate that adherence to cardiology society guidelines is poor, and many patients go without recommended treatment.8-10 In addition, the outlook for patients whose severe MR persists in spite of optimal medical therapy remains poor.11

    Despite meeting the indications for surgical intervention, nearly 50% of MR patients are not candidates for surgery due to comorbidities or advanced age.12 A minimally invasive treatment option that offers an acceptable benefit-risk profile for these patients is needed.

To learn more about the SUMMIT Trial, including eligibility criteria and study locations, please visit the ClinicalTrials.gov website.

Learn more

Landmark study of a minimally invasive device for patients with severe tricuspid regurgitation

The TRILUMINATE™ (Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System) pivotal trial is now enrolling patients in the United States, Canada and Europe, at up to 80 sites.1,2

This prospective, randomized, controlled trial will compare the investigational device (TriClip™ device) to control (medical therapy) in symptomatic patients with severe tricuspid regurgitation (TR). The objective of this trial is to1:

  • Evaluate the safety and effectiveness of the TriClip™ device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery

The TriClip™ device is a clip-based transcatheter tricuspid valve repair (TTVR) system that is delivered via a minimally invasive procedure, with no need for cardiopulmonary bypass or arresting the heart.

CAUTION: TriClip is an investigational device. Limited by Federal (U.S.) law to investigational use only.

  • Eligibility criteria

    Key inclusion criteria1

    Subjects must meet all of the following inclusion criteria in order to participate in the trial:

    • In the judgment of the site’s local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows:
      • Optimized medical therapy for treatment of TR (eg, diuretics)
      • Medical and/or device therapy for mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure
    • The eligibility committee (EC) will confirm that the subject has been adequately treated medically
    • Subject is symptomatic with severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s)
    • The cardiac surgeon of the Site Heart Team concurs that the patient is at intermediate or greater estimated risk of mortality with tricuspid valve surgery
    • New York Heart Association (NYHA) Functional Class II, III, or ambulatory class IV


    Key exclusion criteria1

    • Systolic pulmonary artery pressure (sPAP) > 70 mm Hg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC)
    • Severe uncontrolled hypertension (systolic blood pressure [SBP] ≥ 180 mm Hg and/or diastolic blood pressure [DBP] ≥ 110 mm Hg)
    • Indication for left-sided (eg, severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction in the prior 60 days
    • Left ventricular ejection fraction (LVEF) ≤ 20%
    • Pacemaker or implantable cardioverter defibrillator (ICD) leads that would prevent appropriate placement of the TriClip™ device
    • Any prior tricuspid valve procedure that would interfere with placement of the TriClip™ device
    • Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets, or sufficient reduction in TR. This may include:
      • Evidence of calcification in the grasping area
      • Presence of a severe coaptation defect (> 2 cm) of the tricuspid leaflets
      • Severe leaflet defect(s) preventing proper device placement
      • Ebstein anomaly
    • Tricuspid valve stenosis (tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥ 5 mm Hg as measured by the ECL)
    • Tricuspid valve anatomy not evaluable by TTE and TEE
  • TRILUMINATE PIVOTAL trial design

    TRILUMINATE is a prospective, randomized, controlled, multicenter trial that is enrolling up to 450 subjects.1,2

  • About tricuspid regurgitation

    Tricuspid regurgitation is a condition in which the valve between the two chambers on the right side of the heart does not close properly, resulting in a backward flow of blood into the right chamber of the heart, which can ultimately result in heart failure and death if left untreated.3,4 Approximately 1 in 40 people over the age of 65 have moderate or severe TR.5,6 Medication is routinely prescribed, but only addresses the symptoms of TR. Surgery is an option, but is rarely performed due to the high mortality and morbidity rates associated with the procedure.4 Currently, there are no approved non-surgical, minimally invasive treatments for people with moderate or severe TR.

To learn more about the TRILUMINATE Pivotal Trial, including eligibility criteria and study locations, please visit the ClinicalTrials.gov website.

Learn more

Evaluation of TAVR/TAVI using the Navitor™ valve in a Global Investigation

The purpose of the VANTAGE Trial is to evaluate the safety and effectiveness of the Navitor valve with the FlexNav™ delivery system in an intermediate and low surgical risk patient population in order to support global regulatory approvals. A valve-in-valve cohort across all surgical risk categories is nested within VANTAGE.

Trial participants will play an important role in helping doctors evaluating the use of the Navitor system for patients with severe aortic stenosis.  


CAUTION: Navitor is an investigational device. Limited by Federal (U.S.) law to investigational use only.

  • Eligible patients
    • Diagnosed with severe symptomatic aortic stenosis.
    • Determined by heart team physicians to be low or intermediate surgical risk and a transcatheter valve is appropriate for you.
  • Trial overview

    Before trial enrollment, patients are screened to make sure they are a good candidate for the trial.

    Screening includes:

    • An in-person visit with the heart team physicians which includes the Informed Consent process.
    • An echoardiogram (Echo) to diagnose severe aortic stenosis.
    • A CT-Scan (Computed Tomography) to determine the appropriate valve size. 
    • Medical record review.
    • Blood tests


    What happens after the screening process?

    1. In-person assessment at the treatment center and then registered in the trial.
    2. Transcatheter aortic valve replacement procedure.
    3. Follow-up exams at the following intervals:
      • 30 days
      • 1 year
      • Annual follow-ups through 10 years

     

  • Procedure overview

    Through transfemoral, subclavian or axillary access methods, the Navitor Valve will be introduced in the patient’s body using the FlexNav Delivery System. The delivery system design facilitates gradual, controlled deployment of the valve. Controlled movement of the sheath will be viewed through cardiac fluoro imaging.

    Predilate the native aortic valve with an appropriate diameter native valvuloplasty balloon. Once the sheath is in position, the Navitor valve will be delivered and placed within the opened aortic valve. The Navitor valve is deployed annulus end first from the distal end of the delivery system.

To learn more about the VANTAGE Trial, including eligibility criteria and study locations, please visit the ClinicalTrials.gov website.

Learn more

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