ATLAS (AltaValve) Pivotal Trial

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation, Mitral Incompetence

In brief

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.

Key facts

Study ID

NCT06465745

Run by

4C Medical Technologies, Inc.

People needed

450

Starts

2024-09-03

Expected to finish

2031-09-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Symptomatic New York Heart Association (NYHA) class II-IV.
• Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
• Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
• Exclusion Criteria (Abbreviated List):
• Inability to understand the trial or a history of non-compliance with medical advice.
• Inability to provide signed Informed Consent Form (ICF).
• History of any cognitive or mental health status that would interfere with participation in the trial.
• 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.)).
• Female subjects who are pregnant or planning to become pregnant within the trial period.
• Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
• Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
• Known hypersensitivity to contrast media that cannot be adequately medicated.
• Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
• Concurrent medical condition with a life expectancy of less than 12 months.
• Transcatheter aortic repair or replacement within 90 days prior to the baseline required tests.
• Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.

Where it is running

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

Full record on ClinicalTrials.gov

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