The COAPT Trial

Condition/Intervention:

  • Mitral regurgitation

Study Name:

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (The COAPT Trial)

Phase:

Phase 3

Summary:

The purpose of this study is to examine the safety and effectiveness of an investigational device called the MitraClip® System in patients with functional mitral regurgitation (FMR). The device consists of a delivery catheter and an implantable clip; the catheter guides the MitraClip System into place so that it can be attached to the leaflets (tissue) of the patient's mitral valve. Once the MitraClip is in place on the mitral valve, the delivery catheter is removed.

FMR occurs when the two leaflets of the mitral valve do not close properly, causing blood to leak backward with each heartbeat. If left untreated, patients may begin to show symptoms of heart failure.

Financial interest disclosure: Dr. Kar and Dr. Siegel have a financial relationship with the sponsor of this study as follows:

  • Serve on the advisory board or are consultants for the sponsor

Key Inclusion Criteria:

  • At least 18 years of age
  • Symptomatic functional mitral regurgitation (≥3+) due to cardiomyopathy
  • Subject has been adequately treated per applicable standards
  • New York Heart Association Functional Class II, III or ambulatory IV
  • The Local Site Heart Team and Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject.

Key Exclusion Criteria:

  • Untreated clinically significant coronary artery disease requiring revascularization
  • Coronary artery bypass grafting within prior 30 days
  • Percutaneous coronary intervention within prior 30 days
  • Tricuspid valve disease requiring surgery
  • Aortic valve disease requiring surgery

Please see complete list of inclusion and exclusion criteria.

Principal Investigator:

Saibal Kar, MD

Co-Investigators Include:

Reza Arsanjani, MD
Babak Azarbal, MD
Lawrence Czer, MD
Robert Siegel, MD

Study Coordinator and Contact:

Mane Arabyan
Phone: 310-248-8515
Email: mane.arabyan@cshs.org

Status:

Active

IRB No.:

29657

Date Last Updated:

04/15