The FDA recently approved two investigational device exemption trials that will examine devices for patients undergoing transcatheter aortic valve replacement (TAVR).
The SAPIEN 3 THV PARTNER 3 trial, which is sponsored by Edwards Lifesciences, will examine the safety and effectiveness of the company’s Sapien 3 transcatheter heart valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement.
The primary endpoint of the prospective, randomized, controlled, multicenter study will be a composite of all-cause mortality, all stroke and re-hospitalization for one year after the procedure.
The FDA approved the Sapien 3 system in June 2015 to treat high-risk patients with severe aortic stenosis.
The study is expected to begin in April 2016 and enroll 1,228 patients. They will be randomized to receive the Sapien 3 valve or undergo surgical aortic valve replacement (SAVR). Patients will be at least 65 years old at enrollment and will have follow-up visits at discharge, 30 days and six months and annually for the next 10 years.
The co-principal investigators of the trial are Martin B. Leon, MD, FACC, of Columbia University Medical Center in New York CIty, and Michael J. Mack, MD, FACC, of the Heart Hospital Baylor in Plano, Texas.
The other trial, which is sponsored by Medtronic, will examine Medtronic’s TAVR system in patients at low risk for SAVR. The objective is to evaluate if the Medtronic TAVR system is noninferior to SAVR as measured by rates of all-cause mortality or disabling stroke at two years in patients with severe aortic stenosis and a low predicted risk of operative mortality for SAVR.
The multicenter, prospective, randomized trial is expected to begin enrollment this month. Patients will be examined before and after undergoing TAVR or SAVR, at discharge, 30 days, six months, one year and 18 months and annually through five years.