RECRUITING

AltaValve Pivotal Trial

Talk to us

Conditions

Mitral RegurgitationMitral InsufficiencyMitral Valve IncompetenceMitral Valve RegurgitationMitral IncompetenceTMVRFunctional RegurgitationDegenerative RegurgitationTranscatheter Mitral Valve ReplacementPrimary RegurgitationSecondary Regurgitation

Quick Navigation

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

This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.

Official Title

AltaValve Pivotal Trial

Quick Facts

Study Start:2024-09-03
Study Completion:2031-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06465745

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 CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * Symptomatic New York Heart Association (NYHA) class II-IV.
  3. * Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
  4. * Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
  5. * Inability to understand the trial or a history of non-compliance with medical advice.
  6. * Inability to provide signed Informed Consent Form (ICF).
  7. * History of any cognitive or mental health status that would interfere with participation in the trial.
  8. * Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
  9. * Female subjects who are pregnant or planning to become pregnant within the trial period.
  10. * Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
  11. * Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
  12. * Known hypersensitivity to contrast media that cannot be adequately medicated.
  13. * Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
  14. * Concurrent medical condition with a life expectancy of less than 12 months.
  15. * Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
  16. * Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85032
United States
Sutter Bay Hospitals
San Francisco, California, 94107
United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360
United States
Cardiovascular Institute of the South Clinical Research L.L.C.
Houma, Louisiana, 70360
United States
MedStar Health Research Institute, Inc.
Columbia, Maryland, 21044
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63110
United States
AHS Hospital Corp.
Morristown, New Jersey, 07960
United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
United States
The Charlotte-Mecklenburg Hospital; Atrium Health
Charlotte, North Carolina, 28203
United States
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma, 73135
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: 4C Medical Technologies, Inc.

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 Date2024-09-03
Study Completion Date2031-09

Study Record Updates

Study Start Date2024-09-03
Study Completion Date2031-09

Terms related to this study

Keywords Provided by Researchers

  • Mitral Regurgitation
  • TMVR
  • Functional Regurgitation
  • Degenerative Regurgitation
  • Transcatheter Mitral Valve Replacement
  • Primary Regurgitation
  • Secondary Regurgitation

Additional Relevant MeSH Terms

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