A new clinical trial at Piedmont Heart offers an alternative to open-heart surgery for patients with severe aortic stenosis, the most common and most serious type of heart valve disease in which the opening of the aortic valve is narrowed. Called the Medtronic CoreValveÂ SurgicalÂ Replacement and TranscatheterÂ AorticÂ ValveÂ Implantation (SURTAVI) Trial, the study compares the Medtronic CoreValveÂ®Â System with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk to undergo open-heart surgery.
â€œPatients who undergo the trial procedure will experience a less invasive approach to treating severe aortic stenosis,â€ said Vivek Rajagopal, M.D., the principal investigator for the SURTAVI trial at Piedmont Heart. â€œAs a result, patients may find themselves recovering quicker and staying in the hospital for shorter lengths of time.â€
The SURTAVI trial is the largest global, randomized, controlled trial to evaluate transcatheter aortic valve implantation in less-sick patients who are typically treated with open-heart surgical aortic valve replacement (SAVR).Â The CoreValve System used in the trial is currently limited to investigational use in the United States.
Piedmont Heart is one ofÂ up to 115 clinical sites globally that will enroll approximately 2,500 patients through experienced heart teams including interventional cardiologists and cardiac surgeons.Â The trial will evaluate whether the CoreValve System is non-inferior to surgical valve replacement, based on the composite primary endpoint of all-cause mortality and disabling stroke at 24 months.
Nearly five million Americans are diagnosed with heart valve disease each year, according to the American Heart Association. Approximately 300,000 of those suffer from severe aortic stenosis. Symptoms of aortic stenosis include shortness of breath; chest pain, pressure or tightness; fainting; palpitations or a feeling of heavy, pounding or noticeable heartbeats; and a decline in activity level or reduced ability to do normal activities requiring mild exertion. Sometimes, patients do not experience symptoms at all.