Innovation and Clinical Trials for Structural Heart Disease
Clinical trials test the use and effectiveness of new devices and treatment techniques, after careful consideration of their likely safety. If you’re eligible, choosing to participate in a clinical trial can help advance care for the public and also give you early access to promising treatments.
Our program has a long history with these efforts, leading clinical trials and joining many others. In fact, when you come to us for care, you’ll find trials available only at select programs. Our innovations lead to significant progress treating structural heart disease, and we offer options aimed at longer and healthier life.
Talk to your doctor to see if a clinical trial is right for you.
Our innovations for structural heart disease
Clinical studies at Henry Ford Health System have helped create new devices and techniques for treating structural heart diseases. Some of our research accomplishments include:
- Testing devices to reduce stroke risk: For people with atrial fibrillation, special devices can close the heart’s left atrial appendage (LAA). We helped secure approval for these devices, which prevent blood clots from leaving the heart and causing strokes.
- Developing the BASILICA procedure: Henry Ford doctors participated in clinical research to develop the BASILICA procedure. This minimally invasive technique helps make transcatheter aortic valve replacement (TAVR) safer.
Our current research efforts
Many of our recent and current clinical trials focus on developing additional minimally invasive techniques for heart valve repair and replacement:
- Tendyne valve: This replacement valve corrects mitral valve regurgitation and is the only device of its kind doctors can reposition and retrieve, if necessary.
- SAPIEN M3 valve: This replacement valve corrects severe mitral valve regurgitation in people who can’t have surgery.
- CLASP study: This study involves the Edwards PASCAL Transcatheter Mitral Valve Repair System. The system is designed to treat leaking mitral valves.
How clinical trials work
Clinical trials generally progress through four phases. Each phase evaluates different aspects of a new medication or procedure:
- Phase I: Researchers investigate new treatments to determine how they should be given/performed and how long they will last, as well as to further evaluate their safety.
- Phase II: Researchers begin to evaluate how well a new treatment works.
- Phase III: During this phase, doctors compare the new treatment to current, standard treatments for a specific condition. In many cases, Phase III clinical trials enroll large numbers of people.
- Phase IV: The last phase of a clinical trial occurs after the Food and Drug Administration (FDA) approves the new medication or procedure. Investigators monitor the safety of the new treatment for its long-term effects in large population groups.