RECRUITING

AltaValve Early Feasibility Study Protocol

Conditions

Mitral Regurgitation Mitral Insufficiency Mitral Valve Incompetence Mitral Valve Regurgitation Mitral Incompetence TMVR Functional Regurgitation Degenerative Regurgitation Transcathether Mitral Valve Replacement Primary Regurgitation Secondary Regurgitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

AltaValve Early Feasibility Study Protocol

Quick Facts

Study Start:2019-12-04

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03997305

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Adam Lawrence

CONTACT

+1-727-318-2203

AltaValveEFS@4CMed.com

Principal Investigator

Philippe Genereux, MD

PRINCIPAL_INVESTIGATOR

Morristown Medical Center

Vinayak Bapat, MD

PRINCIPAL_INVESTIGATOR

Allina Health System

Study Locations (Sites)

Tucson Medical Center

Tucson, Arizona, 85712

United States

Los Robles Regional Medical Center

Thousand Oaks, California, 91360

United States

MedStar Washington Hospital

Washington, District of Columbia, 20010

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Emory University

Atlanta, Georgia, 30308

United States

Cardiovascular Institute of the South

Houma, Louisiana, 70360

United States

Morristown Medical Center

Morristown, New Jersey, 07960

United States

Atrium Health

Charlotte, North Carolina, 28203

United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73135

United States

Baptist Memorial Hospital - Memphis

Memphis, Tennessee, 38120

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Baylor Scott & White

Plano, Texas, 75093

United States

Collaborators and Investigators

Sponsor: 4C Medical Technologies, Inc.

Philippe Genereux, MD, PRINCIPAL_INVESTIGATOR, Morristown Medical Center
Vinayak Bapat, MD, PRINCIPAL_INVESTIGATOR, Allina Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-04

Study Completion Date2025-09

Study Record Updates

Study Start Date2019-12-04

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

Mitral Regurgitation
TMVR
Functional Regurgitation
Degenerative Regurgitation
Transcathether Mitral Valve Replacement
Primary Regurgitation
Secondary Regurgitation

Additional Relevant MeSH Terms

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