Medtronic begins enrollment for CoreValve in intermediate-risk patients
Medtronic has enrolled its first patient in a global, multicenter, randomized clinical trial comparing the Medtronic CoreValve system with surgical aortic valve replacement in patients with severe aortic stenosis who are at intermediate risk to undergo open-heart surgery.
The trial, called Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial, will evaluate the potential for the minimally invasive CoreValve system to be considered for less-sick patients who typically are treated with open-heart surgical aortic valve replacement (SAVR).
Edwards Lifesciences' Sapien valve recently was recommended for approval from an FDA panel for this patient population, based on the PARTNER Cohort A data.
The first patient procedures in the SURTAVI trial occurred at Rigshospitalet Copenhagen University Hospital in Copenhagen, Denmark, and were performed by Lars Søndergaard, MD, interventional cardiologist, and Daniel A. Steinbrüchel, MD, DMSc, cardiaothoracic surgeon.
The trial will nominally evaluate approximately 2,500 patients at up to 75 clinical sites with experienced heart teams that include interventional cardiologists and cardiac surgeons. 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 major stroke at 24 months.
Minneapolis-based Medtronic said it is working with the FDA to include U.S. patients in the trial.
Patients considered for the trial include those with severe, symptomatic aortic stenosis who are classified as intermediate surgical risk, as defined by a Society of Thoracic Surgeons’ (STS) mortality risk of 4 percent or more and 10 percent or less. Patients will be randomized on a 1:1 basis to either TAVI with CoreValve or to surgery. CoreValve implantation can be performed by transfemoral, subclavian or direct aortic access, depending on the needs of the patient. All patients will be followed through five years.
The Medtronic CoreValve system received CE Mark in 2007, and is currently limited to investigational use in the U.S.
The trial, called Medtronic CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) Trial, will evaluate the potential for the minimally invasive CoreValve system to be considered for less-sick patients who typically are treated with open-heart surgical aortic valve replacement (SAVR).
Edwards Lifesciences' Sapien valve recently was recommended for approval from an FDA panel for this patient population, based on the PARTNER Cohort A data.
The first patient procedures in the SURTAVI trial occurred at Rigshospitalet Copenhagen University Hospital in Copenhagen, Denmark, and were performed by Lars Søndergaard, MD, interventional cardiologist, and Daniel A. Steinbrüchel, MD, DMSc, cardiaothoracic surgeon.
The trial will nominally evaluate approximately 2,500 patients at up to 75 clinical sites with experienced heart teams that include interventional cardiologists and cardiac surgeons. 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 major stroke at 24 months.
Minneapolis-based Medtronic said it is working with the FDA to include U.S. patients in the trial.
Patients considered for the trial include those with severe, symptomatic aortic stenosis who are classified as intermediate surgical risk, as defined by a Society of Thoracic Surgeons’ (STS) mortality risk of 4 percent or more and 10 percent or less. Patients will be randomized on a 1:1 basis to either TAVI with CoreValve or to surgery. CoreValve implantation can be performed by transfemoral, subclavian or direct aortic access, depending on the needs of the patient. All patients will be followed through five years.
The Medtronic CoreValve system received CE Mark in 2007, and is currently limited to investigational use in the U.S.