Replacement of the mitral valve using a new device for patients with severe mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) System in patients suffering from severe symptomatic mitral regurgitation. It is a multi-center, global, prospective, non-randomized interventional trial where all enrolled subjects will receive the study device. The trial aims to assess the safety and effectiveness of this innovative valve replacement approach for patients who are not suitable for existing treatment options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion Criteria:

* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability

Where it's running

• University of Alabama Birmingham (UAB) Hospital
  Birmingham, Alabama, United States Recruiting
• Abrazo Heart Hospital
  Phoenix, Arizona, United States Recruiting
• PIH Health Good Samaritan Hospital
  Los Angeles, California, United States Recruiting
• Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Keck Hospital of the University of Southern California, USC
  Los Angeles, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David Adams, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Megan Wilder Fredrickson
• Email: rs.tmvrpivotaltrial@medtronic.com
• Phone: 612-469-1749

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.