Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 pressure systolic pressure > 50 mmHg, or LVESD > 40 mm.
  • Subject is at moderate surgical risk defined as being at least 75 years of age, OR if younger than 75 years, then has: (1) Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR (2) Presence of other comorbidities which may introduce a potential surgery-specific impediment.
  • Subject provides written informed consent.
  • Subject is ≥ 18 years of age.

Exclusion Criteria

  • Subject is currently participating in another clinical investigation
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Subject has ischemic or non-ischemic secondary MR
  • Concomitant severe tricuspid valve regurgitation
  • Ejection fraction <30%
  • Severe mitral annular calcification
  • Acute myocardial infarction in the past 12 weeks
  • Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
  • Subjects who have concurrent coronary artery disease may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClipTM device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery
  • Surgical procedure performed in the past 30 days
  • Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
  • Transesophageal echocardiography (TEE) is contraindicated.
  • Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock or the need for inotropic support or IABP
  • Need for emergency surgery for any reason
  • Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
  • Systolic anterior motion of the mitral valve
  • Hypertrophic cardiomyopathy
  • Renal insufficiency requiring dialysis
  • Active infections requiring current antibiotic therapy
  • Subjects who are pregnant or planning to be pregnant

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Control Arm
Mitral Valve Repair Surgery
  • Procedure: Mitral Valve Repair Surgery
    Surgical repair of the mitral valve
Experimental
Device Arm
MitraClip™ device implantation
  • Device: MitraClip™ device implantation
    Transcatheter repair of the mitral valve using MitraClip™ device

Recruiting Locations

Memorial Hermann Hospital
Houston, Texas 77008
Contact:
Elizabeth Turrentine
713-500-5683
elizabeth.p.turrentine@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

Janna Joyner
919-896-9476
janna.joyner@abbott.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.