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AltaValve Pivotal Trial for Mitral Regurgitation

This study is testing a device called the AltaValve System for people with moderate-to-severe or severe mitral regurgitation (a heart condition where the mitral valve doesn't close properly, causing blood to leak backward). You might be able to join if you are at least 18 years old, have symptoms like shortness of breath or fatigue (NYHA class II-IV), and your doctors have determined that surgery or another procedure called TEER is not suitable for you. The study aims to see how safe and effective the AltaValve System is. Success in this study will be measured by a combination of all-cause mortality (death from any cause) or hospitalization for heart failure, observed over 12 months. The current recruitment status is unclear.

Study design
This is a prospective, single-arm study, meaning all participants will receive the AltaValve System. It is planned to include 450 participants across multiple medical centers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to assess the study's main outcomes.

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NCT06465745

ATLAS (AltaValve) Pivotal Trial

Recruiting
NAAges 18+InterventionalTreatment
4C Medical Technologies, Inc.
~450 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:AltaValve System.

At a glance

Recruiting sites
58 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of all-cause mortality or heart failure hospitalization.
Measured over 12 months.

Conditions

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

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Mitral Valve Insufficiency

Where it's being run

58 sites across 27 states
Germany8
California5
Arizona4
France4
Florida3
Michigan3
Greece3
Spain3

Who to contact

Paul Sorajja
[email protected]
602-521-3090
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Composite of all-cause mortality or heart failure hospitalization.12 months.