CLINICAL TRIALS

ONGOING RESEARCH
FOR BETTER EVIDENCE

WHY SHOULD I
JOIN A CLINICAL TRIAL?


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

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

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.

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.

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.

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 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

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

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