AltaValve for Mitral Valve Regurgitation
What You Need to Know Before You Apply
What is the purpose of this trial?
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known allergy to aspirin, heparin, or Warfarin, you must have an adequate alternative medication.
Is the AltaValve system safe for humans?
The AltaValve system is designed for transcatheter mitral valve replacement (TMVR) and aims to address anatomical challenges in treating mitral valve regurgitation. While specific safety data for AltaValve is not detailed, TMVR procedures generally involve risks such as procedural invasiveness and the need for anticoagulation (blood-thinning medication). Randomized controlled trials are recommended to better understand the safety and effectiveness of TMVR devices like AltaValve.12345
How is the AltaValve treatment different from other treatments for mitral valve regurgitation?
The AltaValve treatment is unique because it is designed to overcome anatomical challenges in transcatheter mitral valve replacement (TMVR), such as the complex shape of the mitral valve area and potential interactions with nearby heart structures, making it a promising option for patients who are not suitable for traditional surgery.16789
What data supports the effectiveness of the AltaValve treatment for Mitral Valve Regurgitation?
The AltaValve system is designed for transcatheter mitral valve replacement (TMVR) and aims to address anatomical challenges that other TMVR devices face. While specific data on AltaValve's effectiveness is not provided, TMVR has shown potential as a safe and effective treatment for patients with severe mitral valve disease who are not suitable for surgery.1461011
Who Is on the Research Team?
Philippe Genereux, MD
Principal Investigator
Morristown Medical Center
Vinayak Bapat, MD
Principal Investigator
Allina Health System
Are You a Good Fit for This Trial?
This trial is for adults over 18 with moderate to severe mitral valve regurgitation who are at high risk for open-heart surgery. Participants should have symptoms classified as NYHA II-IV and cannot be pregnant, planning pregnancy, or enrolled in other conflicting studies. They must not have allergies to nitinol or contrast media that can't be managed with medication.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the AltaValve procedure for the treatment of mitral valve regurgitation
Follow-up
Participants are monitored for safety and effectiveness after the AltaValve procedure
What Are the Treatments Tested in This Trial?
Interventions
- AltaValve
Find a Clinic Near You
Who Is Running the Clinical Trial?
4C Medical Technologies, Inc.
Lead Sponsor