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 that may not otherwise be available, usually comparing the intervention with a device against a control group.
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.
Contribute to new discoveries or improved treatment options for other patients now and in 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.
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!
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.
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.
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.
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.
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.
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.
The PROGRESS trial will evaluate if the SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valves (THV) are beneficial in patients with moderate, calcific aortic stenosis versus careful observation (or clinical surveillance). Currently, SAPIEN 3 and SAPIEN 3 Ultra THV are approved for patients with symptomatic severe aortic stenosis.
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.
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CAUTION – Investigational devices. Limited by Federal (United States) law to investigational use.
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