AltaValve Pivotal Trial

Not Applicable

Recruiting

• Conditions: Mitral Incompetence; Mitral Valve Incompetence; Mitral Regurgitation; Mitral Insufficiency; Mitral Valve Regurgitation

• Registration Number: NCT06465745
• Lead Sponsor: 4C Medical Technologies, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-20
• Study Start: 2024-09-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2029-09
• Study Completion: 2031-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite of all-cause mortality or heart failure hospitalization.	12 months.

Secondary Outcome Measures

Name	Time	Method
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).	6 months and 1 year.	Quality of life improvement.
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).	Composite.
Technical success.	Day 0.	Technical success will be considered achieve when all of the following are present: * Successful application of the delivery system as intended.; * Successful device placement.; * Reduction in mitral regurgitation grade to ≤ 2+.
Mitral valve re-intervention.	At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.	Mitral valve re-intervention after index procedure
Changes in Six-minute walk test (6MWT).	6 months and 1 year.	Quality of life improvement.
New pacemaker rate.	1 month, 6 months and 1 year.

Trial Locations

Locations (29)

Abrazo Arizona Heart Hospital; 🇺🇸 Phoenix, Arizona, United States

Dignity Health; St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

TMC Healthcare; 🇺🇸 Tucson, Arizona, United States

Sutter Bay Hospitals; 🇺🇸 San Francisco, California, United States

Los Robles Hospital & Medical Center; 🇺🇸 Thousand Oaks, California, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

MedStar Health Research Institute, Inc.; 🇺🇸 Columbia, Maryland, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

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