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Clinical research trial information for patients and care partners

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family
family

What is a clinical trial?


A clinical trial involving a medical device is a voluntary study conducted in people and designed to answer specific questions about the safety and effectiveness of the device for a specific use or a use that may not otherwise be available, usually comparing the intervention with a device against a control group.

Why should I participate?

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Icon of mobile phone
Icon of mobile phone

Access to latest technology

Receive a treatment or therapy that may not otherwise be available or better understand its effectiveness, typically at little to no additional cost to you.

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magnifying glass heart icon
magnifying glass heart icon

Contribute to research

Contribute to new discoveries or improved treatment options for other patients now and in the future.

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90
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Give hope for the future

While there may or may not be benefits to you, the results of a trial may benefit the people who come after you.

Note: There are risks to taking part in clinical trials. There may be unpleasant, serious, or even life-threatening effects of experimental treatment. Risks specific to each study are described in the informed consent documents.

Diversity & Inclusion

mom and daughter
mom and daughter
mom and daughter

Gender and ethnic differences matter in the selection process as some conditions are more prevalent in certain groups. No matter who you are, please consider participating to see if you qualify!

mom and daughter
mom and daughter
mom and daughter

Find a trial that's right for you

alliance trial
alliance trial
alliance trial
The ALLIANCE trial

The ALLIANCE trial will explore whether the SAPIEN X4 transcatheter heart valve (THV) is beneficial for patients with symptomatic, severe, calcific aortic stenosis. The ALLIANCE trial will also explore whether the SAPIEN X4 transcatheter heart valve is beneficial for patients with a failing aortic bioprosthetic valve. This trial is currently enrolling.

View the ALLIANCE trial clinical trial site
alt-flow trial
alt-flow trial
alt-flow trial
The ALT-FLOW II trial

The ALT-FLOW II clinical trial is studying the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt, a device designed to relieve symptoms due to certain types of heart failure. This trial is enrolling participants with an ejection fraction > 40% that are experiencing heart failure symptoms despite being on guideline-directed medical therapy.

View the ALT-FLOW II trial clinical trial siteView details on ClinicalTrials.gov
clasp II tr trial
clasp II tr trial
clasp II tr trial
The CLASP II TR trial

The CLASP II TR clinical trial study is to determine the safety and effectiveness of the Edwards PASCAL transcatheter valve repair system, a device designed to repair the tricuspid valve with no open heart surgery.
This trial is meant for patients with severe, symptomatic tricuspid regurgitation, despite current medical therapy. Talk to your doctor to determine if this trial is right for you.

View the CLASP II TR trial clinical trial siteView details on ClinicalTrials.gov
clasp trial
clasp trial
clasp trial
The CLASP IID trial

The CLASP IID clinical trial studies the Edwards PASCAL transcatheter valve repair system, a device designed to repair the mitral valve with no open heart surgery. The trial is meant for patients with mitral regurgitation who are prohibitive-risk candidates for open heart surgery. Talk to your doctor to determine if this trial is right for you.

View the CLASP IID trial clinical trial siteView details on ClinicalTrials.gov
clasp iif trial
clasp iif trial
clasp iif trial
The CLASP IIF trial

The CLASP IIF clinical trial studies the Edwards PASCAL transcatheter valve repair system, a device designed to repair the mitral valve with no open heart surgery. This trial is meant for patients with greater than moderate and symptomatic functional mitral regurgitation (FMR). Talk to your doctor to determine if this trial is right for you.

View the CLASP IIF trial clinical trial siteView details on ClinicalTrials.gov
early tavr trial
early tavr trial
early tavr trial
The EARLY TAVR trial

The EARLY TAVR trial is no longer enrolling patients. The EARLY TAVR trial will examine the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra transcatheter heart valve (THV) versus careful observation (or clinical surveillance) in patients with severe calcific aortic stenosis without symptoms.

View the EARLY TAVR trial clinical trial siteView details on ClinicalTrials.gov
ENCIRCLE Trial
ENCIRCLE Trial
ENCIRCLE Trial
The ENCIRCLE trial

The ENCIRCLE trial studies the SAPIEN M3 system, a device designed to replace the mitral valve without open heart surgery.  This trial is meant for patients with a mitral regurgitation grade of at least 3+ for whom commercially available surgical or transcatheter treatment options are unsuitable.

View the ENCIRCLE trial clinical trial siteView details on ClinicalTrials.gov
The HPI CARE Trial (PCP)
The HPI CARE Trial (PCP)
The HPI CARE Trial (PCP)
The HPI CARE trial

The HPI Care trial is designed to determine whether the use of the Acumen Hypotension Prediction Index (HPI) software to guide hemodynamic management in patients undergoing cardiac surgery requiring cardiopulmonary bypass reduces the mean duration of hypotension (defined as MAP < 65 mmHg) from the post-bypass period in the cardiac operating room (OR) and the cardiovascular intensive care unit (CVICU). The Acumen HPI software is used on-label in the HPI-CARE Trial and is not an investigational device.

View the HPI CARE trial clinical trial siteView details on ClinicalTrials.gov
The PROGRESS Trial (PCP) Logo
The PROGRESS Trial (PCP) Logo
The PROGRESS Trial (PCP) Logo
The PROGRESS trial

The PROGRESS trial will evaluate if the SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valves (THV) are beneficial in patients with moderate, calcific aortic stenosis versus careful observation (or clinical surveillance). Currently, the study devices are approved for patients with symptomatic severe aortic stenosis.

View the PROGRESS trial clinical trial siteView details on ClinicalTrials.gov
TRISCEND II Trial
TRISCEND II Trial
TRISCEND II Trial
The TRISCEND II trial

The TRISCEND II clinical trial is to determine the safety and effectiveness of the EVOQUE valve, a device designed to replace the tricuspid valve with no open heart surgery. This trial is for patients with severe or greater tricuspid regurgitation.

View the TRISCEND II trial clinical trial siteView details on ClinicalTrials.gov
contact us lady
contact us lady
contact us lady

We're here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.

Give us a call

888.713.1564
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AdvaMed Logo
AdvaMed Logo

As a member of the Advanced Medical Technology Association (“AdvaMed”), Edwards strictly adheres to the requirements of the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

Caution: Investigational device

Limited by Federal (United States) law to investigational use.