Ascension | Ascension Texas Cardiovascular
Status
Conditions
Treatments
About
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure > 50 mmHg, or LVESD > 40 mm
Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have:
Subject provides written informed consent
Subject is ≥ 18 years of age
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
500 participants in 2 patient groups
Loading...
Central trial contact
Janna Joyner
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal