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Stay Informed
CLINICAL TRIALS

ONGOING RESEARCH
FOR BETTER EVIDENCE

WHY SHOULD I
JOIN A CLINICAL TRIAL?

Hospitalization


ACCESS INVESTIGATIONAL THERAPIES

By playing an active role in your own healthcare, you have an opportunity to receive innovative, potentially life-extending treatment before it’s commercially available.

Contribute to Research


CONTRIBUTE TO
RESEARCH

Medical researchers need real-world data to bring these innovative therapies to market, your participation in a trial can give more options to future patients.

Improved future outcomes


IMPROVED FUTURE
OUTCOMES

In order to learn more about diseases and treatments researchers need a diverse patient population to participate in the trials. Your participation may benefit others like you.

As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help find the answers.
 
You should talk to your doctor to determine if trial participation is right for you. Before deciding to participate, carefully consider risks and possible benefits. The specific risks associated with a research protocol are described in an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. A member of the research team will explain the study requirements and answer any questions about the informed consent document.

AORTIC STENOSIS

The ENVISION Clinical Trial is studying the Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System in patients with severe, symptomatic aortic stenosis who are deemed low or intermediate surgical risk. Approximately 1,300 patients will be studied at up to 80 medical centers in the United States and Canada.


CAUTION: The Navitor TAVI System (for ENVISION Clinical Trial indications) is an investigational device. Limited by Federal (U.S.) law to investigational use only.

Visit the ENVISION Trial page

ATRIAL FIBRILLATION

For people with atrial fibrillation (AFib), irregular electrical impulses in the upper chambers can cause an increased risk for developing blood clots, which can lead to a stroke. The left atrial appendage can be a major source of blood clots in patients with AFib. The CATALYST clinical trial will evaluate the safety and effectiveness of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder compared to the treatment of blood thinner medication in patients with non-valvular AFib who are at an increased risk for stroke and who are recommended for long-term blood thinner medication.


CAUTION: The Amplatzer Amulet device (for CATALYST indications) is an investigational device. Limited by Federal (U.S.) law to investigational use only.

Visit the Catalyst Trial page

MITRAL REGURGITATION

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 75 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.

Visit the Repair MR Trial page

CLINICAL TRIALS

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 40 planned clinical trials in the Structural Heart division, 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 limited by Federal (U.S.) law to investigational use only.

Clinical Evidence

Clinical Research

"What separates Structural Heart is an absolute dedication and passion to do clinical studies at the highest possible level.”

Neil Moat
Divisional Vice President, Medical Affairs and Chief Medical Officer

Clinical Trials

Diversity in Clinical Trials

"As an industry, we need to set new standards to make sure that our clinical trials remain representative of the people our products are designed to help.”

Barathi Sethuraman
Divisional Vice President, Global Clinical Affairs

MAT-2301099 v5.0 | Item approved for U.S. use only.

Important Safety Information
  • Navitor
  • Amplatzer Amulet LAAO
  • MitraClip G4

  • WHAT IS THE NAVITOR™ TAVI SYSTEM APPROVED FOR?
    Available by prescription only.

    Transcatheter Aortic Valve Implantation (TAVI) with the Navitor™ TAVI System provides an alternative, minimally invasive treatment option for people living with severe aortic stenosis, a condition where the aortic valve does not fully open or close, who are not candidates for open-heart surgery due to age, frailty, or other conditions that make surgery too risky.

    WHO SHOULD NOT RECEIVE TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    You should not receive the Navitor valve if you have any of the following conditions: any kind of infection, including an active infection in the heart; cannot tolerate medication that thins the blood or prevents blood clots from forming; have a reaction or allergy to nitinol, an alloy of nickel and titanium.

    The Navitor™ TAVI System has not been studied in the following patient populations and therefore should not be used in patients who: have any evidence of a blood clot (thrombus), intracardiac mass or vegetation in, on or around the heart; have narrow veins or arteries with calcification that make insertion of the delivery sheath and access to the aortic valve impossible; have stenotic (narrowed) aortic valve without calcium deposits; have a heart valve defect from birth with either one or two leaflets vs. the normal three leaflets; are pregnant or breastfeeding; are age 21 or younger at the time of diagnosis or treatment; have an ejection fraction, or volume of blood fluid, less than 20%; have unstable heart function requiring mechanical assistance or drug therapy to support the normal function of the heart; are low or intermediate surgical risk; have had a previous heart valve or ring in any position in the heart; have mixed aortic valve disease (stenosis and regurgitation); have severe mitral valve disease (calcification, stenosis or inefficiency); have a medical condition that affects the cellular or plasma components of the blood; have significant coronary artery disease that requires treatment; have abnormally thick heart muscle (hypertrophic cardiomyopathy); are on dialysis, have kidney failure or inefficiency; have known allergy or sensitivity to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media/dye; have bulky calcium build up on the valve leaflets close to the coronary ostia which are the main arteries delivering blood from the heart to the rest of the body; have significant aortic disease, including abdominal aorta, thoracic aneurysm or any other folding, bending or narrowing which would make access to the aortic valve impossible.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE NAVITOR™ TAVI SYSTEM?

    There are risks with any heart valve implantation procedure. The most serious risks are: death, stroke, serious damage to the arteries and serious bleeding. Additional risks include, but are not limited to: access site complications (e.g., pain, bleeding, infection, blood vessel damage); buildup of deposits (plaque) in and on the walls of coronary arteries; heart attack - blockage of blood flow to the heart muscle; allergic reaction to medication or products/devices used during the procedure (medication to prevent blood clotting, x-ray die, components of the valve delivery process); tear or burst of the aorta; irregular heart rate; disruption or injury of electrical system in your heart leading to the need for a permenant pacemaker implant; tear or separation of the layers of the wall of an artery; obstruction of an artery, typically by a clot of blood or an air bubble; inflammation of the lining of your heart; failure of your heart to pump enough blood to the body’s organs; unstable blood flow; rupture or destruction of blood cells; blood cell damage; low red blood cell count; bleeding, infection, clotting in or on the valve or tissue of the valve; loose clots in the bloodstream that may block an artery in your arms, legs, or brain; escape of blood from a ruptured blood vessel; blood pressure changes above or below the normal levels; infection; reduced blood flow to your heart, preventing the heart muscle from receiving enough oxygen; changes to the Mitral valve where it doesn’t close tightly; multi-organ failure - inflammation from a severe infection or injury causes dysfunction in two or more organ systems; wrong sizing or positioning of the implanted valve; collection of fluid or blood around your heart; perforation or tear of the heart muscle, ventricle or blood vessel; formation of scar tissue that may cover or block the valve from functioning normally; leakage of blood around the edge of the valve; valves in your heart don’t close tightly, allowing blood to flow backward in your heart; kidneys lose the ability to remove waste and balance fluids; blood doesn’t have enough oxygen or has too much carbon dioxide; sepsis; structural deterioration of the implanted valve (i.e., calcification, leaflet tear); having an abnormal particle (air or blood clots) floating in the bloodstream or attached to an object, including the valve; when extra fluid builds up in the space around the heart; when the transcatheter valve moves or is dislodged from the deployment position/location; permanent disability; the need for additional medical procedures to include blood transfusions, operation to remove the valve, use of a balloon to adjust the valve (valvuloplasty), and catheter insertion into coronary arteries to treat blockages.

  • WHAT IS THE AMPLATZER™ AMULET™ LEFT ATRIAL
    APPENDAGE (LAA) OCCLUDER APPROVED FOR?
    Available by prescription only.

    The Amplatzer™ Amulet™ LAA Occluder is a device that is placed in the heart during a minimally invasive, catheter-based procedure to prevent blood clots from leaving the LAA in patients with atrial fibrillation who are at increased risk for stroke and are unable to take blood-thinning medication long-term.

    WHO SHOULD NOT RECEIVE THE AMPLATZER™ AMULET™ LAA OCCLUDER?

    Patients who have any of the following conditions should not receive the Amplatzer™ Amulet™ LAA Occluder: blood clots in the heart; active heart infection or other infections; anatomy in which the Amplatzer™ Amulet™ LAA Occluder would interfere with other heart structures, such as valves or veins.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE AMPLATZER™ AMULET™ LAA OCCLUDER?

    The Amulet LAAO procedure carries risks which include, but are not limited to: air bubble that blocks blood flow in a vessel; allergic reaction; anesthesia reactions; nausea; confusion; injury to the airway; difficulty breathing; fainting; loss of regular heart rhythm; a hole in the wall (septum) that separates the heart’s upper chambers; bleeding; low blood count; heart suddenly stops beating; blood or fluid buildup around the heart or lung; chest pain and/ or discomfort; death; obstruction of a blood vessel by all or part of an implanted device that entered the bloodstream; device erosion; device failure; device in wrong position; movement of the device to other parts of the body; blood clot on the device; fever; high or low blood pressure; infection; multiple organ failure; heart attack; perforation of the heart muscle or vessels; heart failure; kidney failure; seizure; continued blood flow into the LAA; temporary or permanent stroke; blood clot, including in the heart, leg, or lung; abnormal backward flow of blood through a valve; injury to the incision site; groin pain; blood clot under the skin in the groin; injury to a blood vessel.

    WHAT ARE THE WARNINGS ASSOCIATED WITH THE AMPLATZER™ AMULET™ LAA OCCLUDER?

    Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Patients may develop a build-up of fluid or blood around the heart and should contact their physician if they experience chest pain or difficulty breathing after implant.

    Talk to your doctor to learn more about the risks associated with the Amplatzer™ Amulet™ LAA Occluder.

  • WHAT IS MITRACLIP™ THERAPY APPROVED FOR?
    Available by prescription only.

    MitraClip therapy is a minimally invasive procedure approved for treating patients with clinically significant mitral regurgitation due to either (a) a deteriorated mitral valve in patients who are deemed to be at prohibitive risk for surgery, or (b) mitral valve in patients who have heart failure and an enlarged heart who remain symptomatic on maximally tolerated medications to treat their heart failure.

    Patients should work with their doctor and a multidisciplinary heart team, which should include a heart surgeon and cardiologist with experience treating heart failure, to confirm their surgical risk or optimal medications. The heart team will determine if the patient meets the indications for the MitraClip procedure.

    WHO SHOULD NOT HAVE THE MITRACLIP PROCEDURE?

    Patients that have any of the following conditions should not have the MitraClip Procedure: inability to tolerate or are allergic or hypersensitive to anti coagulants, anti-platelet therapies, nickel, titanium, cobalt, chromium, polyester, or contrast dye; have inflammation or rheumatic disease of the valve; have blood clots inside the heart or blood vessels (inferior vena cava, femoral vein), or have mitral valve anatomy which is deemed not suitable for repair with Mitraclip.

    WHAT CAN HAPPEN TO ME DURING THE MITRACLIP PROCEDURE?

    As with most medical procedures, MitraClip Implant placement has risks, including inappropriate device placement, device movement from its implanted site, and failed or difficult delivery or retrieval of the device once implanted. Your physician will determine if you fall within the labeled indication for the MitraClip Procedure.

    WHO IS MORE AT RISK DURING THE MITRACLIP PROCEDURE?

    Even though MitraClip Therapy is a minimally invasive medical procedure, it carries risks, and some patients may be at a higher risk than others. If you have either a weak heart that may need support during the procedure or a rotated heart from prior heart surgery, talk to your doctor to weigh the additional risks to the benefits of the MitraClip Procedure as the safety and effectiveness has not been tested in these patients.

    WHAT ARE THE POSSIBLE COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURE?

    The MitraClip Procedure carries risks which include, but are not limited to: Allergic reactions to the implant materials or medications used during or after the procedure; Tissue damage at the puncture (entry site such as wound reopening, reaction to the catheter, bleeding, air bubbles, tissue or nerve injury; Inflammation, buildup of fluid or blood in the sac surrounding the heart, and complications that may require more interventions or heart surgery; Mitral valve complications including device dislodgement, entanglement with chords, narrowing of the mitral valve, continuing backflow of blood through the mitral valve during heart contraction, and inflammation; Abnormal heart rhythm, stroke (resulting from blood clot or burst vessel in the brain or transient stroke, high or low blood pressure; Multiple organ failure, death, pain; Complications related to the echocardiographic imaging such as irritation or perforation of the throat.

    Talk to your doctor to learn more about the risks associated with MitraClip Therapy, and ask for the detailed Important Safety Information if you'd like to review the full list of complications.

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MAT-2302755 v4.0  |   Item approved for U.S. use only.

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