Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial

Study Type/Phase: Pivotal, Multi-center, Global, pre-market trial
Status: Recruiting

This research trial is a Pivotal Study of mitral valve replacement using a new, investigational device called the Medtronic Intrepid™ TMVR system. The purpose of this clinical study is to determine if replacing the mitral valve without surgery is as safe and effective as standard mitral valve open-heart surgery in patients with similar medical conditions.

The Intrepid™ implant is made of a bioprosthetic valve set inside a flexible metal structure that is placed within a patient’s own current mitral valve. The TMVR device is placed through a less invasive procedure, using a catheter introduced through a small incision in the leg, eliminating the need for heart-lung bypass support or stopping the heart in a standard mitral valve replacement surgery.

If your doctors have decided that you are at high risk of experiencing major complications while undergoing open-heart surgery due to your current medical conditions or for anatomical reasons (relating to how and where your heart, mitral valve, and blood vessels are placed within your body) and you meet all of the study exclusion and inclusion criteria, you may be a candidate for the trial.

Speak with your doctor to determine whether you meet the following criteria for this study, partial list below:

Inclusion CriteriaExclusion Criteria
  • You have been diagnosed with symptomatic moderate to severe mitral regurgitation
  • It has been determined by the study site’s heart team that you are unsuitable for treatment with conventional mitral valve intervention.
  • No prior mitral valve procedure that would interfere with the Intrepid device
  • No anatomical contraindications
  • Severe tricuspid regurgitation
  • Severe symptomatic carotid stenosis
  • Evidence of recent TIA or stoke within 90 days

Principal Investigator

Chad Rammohan, MD, Vincent Gaudiani, MD, Deepu Nair MD, Pei Tsau, MD, Rajesh Jaganath, MD, Conrad Vial, MD, Jared Herr, MD, Christian Spies, MD

Sponsor

Medtronic, Inc.

NCT Number

03242642

Contact

Mincy Chakkalakal, Clinical Research Coordinator
650-691-4820
Mincy_Chakkalakal@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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