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ATLAS (AltaValve) Pivotal Trial

RecruitingNA

Sponsor: 4C Medical Technologies, Inc.

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

Interventions: AltaValve System.

Countries: United States, Canada, France, Germany, Greece, Poland, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Locations (58)

Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
San Francisco, California, United States
Thousand Oaks, California, United States
Jacksonville, Florida, United States
Naples, Florida, United States
Sarasota, Florida, United States
Atlanta, Georgia, United States
Houma, Louisiana, United States
Baltimore, Maryland, United States
Columbia, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Morristown, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
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