TRICAV-1
The multicenter TRICAV-1 study evaluates the safety and effectiveness of a catheter-delivered system designed to improve outcomes for adults with symptomatic severe tricuspid regurgitation.
About This Study
Summary
The tricuspid valve acts like a gate between the upper (atrium) and lower (ventricle) chambers on the right side of the heart. When this valve doesn’t close completely, blood can leak backward into the right atrium instead of moving to the lungs to pick up oxygen. This means the heart has to work harder to deliver all the oxygen the body needs.
Approximately 1.5 million U.S. adults have leaky tricuspid valves (tricuspid regurgitation, TR). Many cases of TR are mild, without symptoms, and found by chance. However, if left untreated, TR can lead to reduced heart efficiency and increased mortality, especially in elderly patients. Common symptoms of TR include extreme tiredness, shortness of breath, rapid or irregular heartbeat, and swelling of the liver, abdomen, and legs.
The catheter-delivered device evaluated in TRICAV-1 is designed to decrease heart failure symptoms and the chance of death, stroke, and pulmonary hypertension in participants with severe TR and at high risk for tricuspid valve surgery. Eligible patients who receive the study device will be monitored closely for 1 year and then yearly thereafter, for a total follow-up period of 5 years.
To be included in TRICAV-1, participants must be / have
- Adult (18 years or older)
- Optimal medical therapy for heart failure in place for at least 30 days before planned study procedure
- Confirmed severe tricuspid regurgitation
- Symptomatic heart failure (that is, NYHA Class III to IVa) or hospitalization for heart failure within the past 6 months
To be included in in TRICAV-1, participants must not be / have
- Myocardial infarction, stroke or cardiovascular accident, coronary artery bypass surgery, or other major cardiovascular surgery within 90 days prior to planned study procedure
- Severe right ventricular dysfunction
- Tricuspid stenosis
- Hemodynamically significant pericardial effusion
- Unable to tolerate anticoagulation or antiplatelet therapy
Keywords
Heart failure; Heart valve disease; Structural heart disease; Tricuspid regurgitation
For More About This Study or To Ask About Participation
Additional Information
Jason Foerst, MD, is the medical director of the Structural Heart and Valve Center at Carilion Clinic, assistant professor of medicine at Virginia Tech Carilion School of Medicine, and director of Carilion's structural heart disease fellowship program. Dr. Foerst is a structural interventional cardiologist and researcher who completed his internship, residency, and fellowship training at Dartmouth–Hitchcock/Mary Hitchcock Memorial Hospital.
Official title of study
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I) (TRICAV-I)
Funding mechanism
Industry sponsored by Products & Features