+
+
Stay Informed
Clinical Trials

ONGOING RESEARCH
FOR BETTER EVIDENCE

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 45 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.

WHY SHOULD I
JOIN A CLINICAL TRIAL?


ACCESS INVESTIGATIONAL THERAPIES

By playing an active role in your own healthcare, you have an opportunity to gain access to innovative research treatment before it is commercially available.


CONTRIBUTE TO RESEARCH

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


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.

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 Preseident, Medical Affairs and Chief Medical Officer

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

CATALYST is a clinical trial for atrial fibrillation patients comparing left atrial appendage occlusion therapy to NOACs

THE CATALYST Trial

The CATALYST Trial evaluates the safety and effectiveness of the Amulet Left Atrial Appendage (LAA) occluder compared to Non-vitamin K antagonist oral anticoagulants (NOACs) therapy in patients with non-valvular atrial fibrillation (AFib) at increased risk of ischemic stroke and who are recommended for long-term NOAC therapy. It is a prospective, randomized, multi-center worldwide trial. Talk to your doctor to determine if this trial is right for you.

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

LEARN MORE

REPAIR MR trial will study the MitraClip Transcatheter Mitral Valve Repair system for severe primary 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 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. Talk to your doctor to determine if this trial is right for you.


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

LEARN MORE

MAT-2301099 v2.0 | Item approved for U.S. use only.

Important Safety Information
  • MitraClip
  • Amplatzer Amulet

  • 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.

  • 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 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?

    Potential adverse events that may occur during or after a procedure using this device 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.

Abbott Logo

Making an everlasting
impact On human health
for 130 years

Follow Abbott

Copyright © 2023 Abbott, 3200 Lakeside Dr, Santa Clara, 95054, U.S.A.
Caution: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs. Photos on file at Abbott.
Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

MAT-2004021 v17.0  |   Item approved for U.S. use only.

YOU ARE ABOUT TO ENTER AN ABBOTT COUNTRY OR REGION SPECIFIC WEBSITE.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of the product that are not approved in other countries or regions.

U.S. Health Care Professionals International Health Care Professionals

YOU ARE ABOUT TO LEAVE
www.structural­heart.abbott

You are now leaving www.structuralheart.abbott. Abbott is not responsible for any content published on the third-party website you are about to enter. Abbott has not reviewed and does not endorse any information presented on third-party websites.

OkCancel