Loading clinical trials...

AltaValve Pivotal Trial | Clinical Trials | Clareo Health

RECRUITINGNA

AltaValve Pivotal Trial

NCT06465745•4C Medical Technologies, Inc.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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.
+2 more criteria

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

Key Dates

Start Date

September 3, 2024

Primary Completion Date

September 1, 2029

Completion Date

September 1, 2031

Last Updated

May 2, 2025

Enrollment

450

ESTIMATED participants

Conditions

Mitral RegurgitationMitral InsufficiencyMitral Valve IncompetenceMitral Valve RegurgitationMitral Incompetence

Interventions

AltaValve System.

DEVICE

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

NCT07450911

Mitral Regurgitation

View study

RECRUITINGNA

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

AltaValve Pivotal Trial

Inclusion Criteria

Exclusion Criteria

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease

The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation