AltaValve Early Feasibility Study Protocol

Description

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.

Conditions

Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence

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Study Overview

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Study Details

Study overview

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.

AltaValve Early Feasibility Study Protocol

AltaValve Early Feasibility Study Protocol

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Tucson

Tucson Medical Center, Tucson, Arizona, United States, 85712

Thousand Oaks

Los Robles Regional Medical Center, Thousand Oaks, California, United States, 91360

Washington

MedStar Washington Hospital, Washington, District of Columbia, United States, 20010

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Atlanta

Emory University, Atlanta, Georgia, United States, 30308

Houma

Cardiovascular Institute of the South, Houma, Louisiana, United States, 70360

Morristown

Morristown Medical Center, Morristown, New Jersey, United States, 07960

Charlotte

Atrium Health, Charlotte, North Carolina, United States, 28203

Oklahoma City

Oklahoma Heart Hospital, Oklahoma City, Oklahoma, United States, 73135

Memphis

Baptist Memorial Hospital - Memphis, Memphis, Tennessee, United States, 38120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subjects ≥ 18 years of age.
  • 2. Subjects symptomatic New York Heart Association (NYHA) II-IV.
  • 3. Subjects with severe MR as documented by echo.
  • 4. Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).
  • 1. Inability to understand the study or a history of non-compliance with medical advice.
  • 2. Unwilling or unable to sign the Informed Consent Form (ICF).
  • 3. History of any cognitive or mental health status that would interfere with study participation.
  • 4. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
  • 5. Female subjects who are pregnant or planning to become pregnant within the study period.
  • 6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
  • 7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
  • 8. Known hypersensitivity to contrast media that cannot be adequately medicated.
  • 9. Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
  • 10. Concurrent medical condition with a life expectancy of less than 12 months.
  • 11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

4C Medical Technologies, Inc.,

Philippe Genereux, MD, PRINCIPAL_INVESTIGATOR, Morristown Medical Center

Vinayak Bapat, MD, PRINCIPAL_INVESTIGATOR, Allina Health System

Study Record Dates

2025-09