AltaValve Pivotal Trial

NCT06465745 | Recruiting FDA Device

• 1 other identifier: 5472
• Study Type: interventional
• Target: 450
• Locations: 4 countries
• Sites: 29

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  12 months.

Secondary Outcomes (6)

• All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention.

  30 Days or hospital discharge (whichever is longer).

• Technical success.

  Day 0.

• Mitral valve re-intervention.

  At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.

• Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).

  6 months and 1 year.

• Changes in Six-minute walk test (6MWT).

  6 months and 1 year.

Study Arms (2)

Primary Cohort

EXPERIMENTAL

Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population without at least moderate mitral annular calcification (MAC).

Device: AltaValve System.

Mitral Annular Calcification Cohort (MAC)

EXPERIMENTAL

Designed to evaluate the safety and performance of the AltaValve System for the treatment of moderate-to-severe or severe MR in a targeted patient population with moderate to severe MAC.

Device: AltaValve System.

Interventions

AltaValve System. DEVICE

Transcatheter Mitral Valve Replacement.

Mitral Annular Calcification Cohort (MAC); Primary Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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 index procedure.
• Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.

Sponsors & Collaborators

• 4C Medical Technologies, Inc.: lead

Study Sites (29)

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

RECRUITING

Dignity Health; St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85032, United States

RECRUITING

TMC Healthcare

Tucson, Arizona, 85712, United States

RECRUITING

Sutter Bay Hospitals

San Francisco, California, 94107, United States

RECRUITING

Los Robles Hospital & Medical Center

Thousand Oaks, California, 91360, United States

RECRUITING

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

MedStar Health Research Institute, Inc.

Columbia, Maryland, 21044, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

AHS Hospital Corp.

Morristown, New Jersey, 07960, United States

RECRUITING

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, 10032, United States

NOT YET RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

The Charlotte-Mecklenburg Hospital; Atrium Health

Charlotte, North Carolina, 28203, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

South Oklahoma Heart Research, LLC.

Oklahoma City, Oklahoma, 73135, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Universitatsklinikum Bonn

Bonn, Germany

RECRUITING

University Hospital Cologne - Heart Center

Cologne, Germany

RECRUITING

Cardiac Research GmbH; St.-Johannes-Hospital Dortmund

Dortmund, Germany

RECRUITING

Heart Center Trier

Trier, Germany

RECRUITING

Onassis Cardiac Surgery Center

Athens, Greece

RECRUITING

Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

RECRUITING

Hospital Clinic de Barcelona

Barcelona, Spain

RECRUITING

Fundación para la investigación biomédica del hospital clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, Spain

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 20, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: May 2, 2025

Record last verified: 2025-03

Locations

ES (3); US (20); GR (2); DE (4)