AltaValve Pivotal Trial

April 30, 2025 updated by: 4C Medical Technologies, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
          • Principal Investigator
          • Phone Number: +49 170-3750855
      • Cologne, Germany
        • Recruiting
        • University Hospital Cologne - Heart Center
        • Contact:
          • Principal Investigator
          • Phone Number: +49 221 478-0
      • Dortmund, Germany
        • Recruiting
        • Cardiac Research GmbH; St.-Johannes-Hospital Dortmund
        • Contact:
          • Principal Investigator
          • Phone Number: +49 0231.952 971-0
      • Trier, Germany
        • Recruiting
        • Heart Center Trier
        • Contact:
          • Principal Investigator
          • Phone Number: +49 (0)651 97544-0
  • Greece
      • Athens, Greece
        • Recruiting
        • Onassis Cardiac Surgery Center
        • Contact:
          • Principal Investigator
          • Phone Number: +30 21 0949 3000
      • Thessaloniki, Greece
        • Recruiting
        • Interbalkan Medical Center of Thessaloniki
        • Contact:
          • Principal Investigator
          • Phone Number: +30 231 040 0000
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic De Barcelona
        • Contact:
          • Principal Investigator
          • Phone Number: +34 932 27 54 00
      • Madrid, Spain
        • Recruiting
        • Fundación para la investigación biomédica del hospital clínico San Carlos
        • Contact:
          • Principal Investigator
          • Phone Number: +34 913 30 37 93
      • Vigo, Spain
        • Recruiting
        • Hospital Álvaro Cunqueiro
        • Contact:
          • Principal Investigator
          • Phone Number: +34 986 81 11 11
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Abrazo Arizona Heart Hospital
        • Contact:
          • Principal Investigator
          • Phone Number: 602-532-1000
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Dignity Health; St. Joseph's Hospital and Medical Center
        • Contact:
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • TMC HealthCare
        • Contact:
          • Principal Investigator
          • Phone Number: 520-327-5461
    • California
      • San Francisco, California, United States, 94107
      • Thousand Oaks, California, United States, 91360
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Contact:
    • Maryland
      • Columbia, Maryland, United States, 21044
        • Recruiting
        • MedStar Health Research Institute, Inc.
        • Contact:
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospital
        • Contact:
          • Principal Investigator
          • Phone Number: 248-551-1235
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
          • Principal Investigator
          • Phone Number: 877-800-2729
          • Email: info@mhif.org
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Principal Investigator
          • Phone Number: 800-664-4542
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Contact:
          • Principal Investigator
          • Phone Number: 314-747-6800
          • Email: hrpo@wustl.edu
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • AHS Hospital Corp.
        • Contact:
          • Principal Investigator
          • Phone Number: 973-971-5000
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
      • New York, New York, United States, 10032
        • Not yet recruiting
        • New York Presbyterian Hospital-Columbia University Medical Center
        • Contact:
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • The Charlotte-Mecklenburg Hospital; Atrium Health
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Principal Investigator
          • Phone Number: 833-788-7425
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Recruiting
        • South Oklahoma Heart Research, LLC.
        • Contact:
          • Principal Investigator
          • Phone Number: 405-628-6000
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Cohort
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.
Transcatheter Mitral Valve Replacement.
Experimental: Mitral Annular Calcification Cohort (MAC)
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.
Transcatheter Mitral Valve Replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of all-cause mortality or heart failure hospitalization.
Time Frame: 12 months.
12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 30 Days or hospital discharge (whichever is longer).
Composite.
30 Days or hospital discharge (whichever is longer).
Technical success.
Time Frame: 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+.
Day 0.
Mitral valve re-intervention.
Time Frame: At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.
Mitral valve re-intervention after index procedure
At 30 days, 6 months, 1 year, and annually thereafter for up to 5 years.
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time Frame: 6 months and 1 year.
Quality of life improvement.
6 months and 1 year.
Changes in Six-minute walk test (6MWT).
Time Frame: 6 months and 1 year.
Quality of life improvement.
6 months and 1 year.
New pacemaker rate.
Time Frame: 1 month, 6 months and 1 year.
1 month, 6 months and 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

4C Medical Technologies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 13, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5472

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Regurgitation

Clinical Trials on AltaValve System.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe