πŸ›οΈ Verified NIH Record β€’ Updated 2026-07-31

ATLAS (AltaValve) Pivotal Trial (NCT06465745)

ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial

🟒 Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: 4C Medical Technologies, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Banner University Medical Center β€” Phoenix, Arizona

Age range: 18 Years

πŸ§ͺ Interventions in This Study

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (58 Sites)

Showing the first 25 of 58 sites.

  • Banner University Medical Center β€” Phoenix, Arizona
  • Abrazo Arizona Heart Hospital β€” Phoenix, Arizona
  • Dignity Health; St. Joseph's Hospital and Medical Center β€” Phoenix, Arizona
  • TMC Healthcare β€” Tucson, Arizona
  • Scripps Health β€” La Jolla, California
  • Cedars-Sinai Medical Center β€” Los Angeles, California
  • Orange County Heart Institute & Research Center β€” Orange, California
  • Sutter Bay Hospitals β€” San Francisco, California
  • Los Robles Hospital & Medical Center β€” Thousand Oaks, California
  • Baptist Medical Center β€” Jacksonville, Florida
  • NCH Healthcare System β€” Naples, Florida
  • Sarasota Memorial Health Care System β€” Sarasota, Florida
  • Wellstar Center for Cardiovascular Care β€” Atlanta, Georgia
  • Cardiovascular Institute of the South β€” Houma, Louisiana
  • MedStar Health Research Institute, Inc. β€” Baltimore, Maryland
  • MedStar Health Research Institute, Inc. β€” Columbia, Maryland
  • Beth Israel Deaconess Medical Center β€” Boston, Massachusetts
  • University of Michigan β€” Ann Arbor, Michigan
  • Henry Ford Hospital β€” Detroit, Michigan
  • William Beaumont Hospital β€” Royal Oak, Michigan
  • Minneapolis Heart Institute Foundation β€” Minneapolis, Minnesota
  • Mayo Clinic β€” Rochester, Minnesota
  • Saint Luke's Hospital of Kansas City β€” Kansas City, Missouri
  • Washington University β€” St Louis, Missouri
  • AHS Hospital Corp. β€” Morristown, New Jersey

πŸ“ž Contact the Study Coordinator

Phone: (602) 521-3090

Email: PBC-TREO-CR@arizona.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—