AltaValve Early Feasibility Study Protocol

August 31, 2023 updated by: 4C Medical Technologies, Inc.
Prospective, single-arm, multicenter study to evaluate the safety and performance of the AltaValve for the treatment of moderate to severe or severe mitral valve regurgitation in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

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 Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Tucson Medical Center
        • Contact:
        • Principal Investigator:
          • Tom Waggoner, DO
        • Principal Investigator:
          • George Makdisi, MD
    • California
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Saibal Kar, MD
        • Principal Investigator:
          • Gregory Fontana, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital
        • Contact:
        • Principal Investigator:
          • Ron Waksman, MD, FACS
        • Principal Investigator:
          • Christian Shults, MD, FACS
    • Florida
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • Lucian Lozonschi, MD
        • Principal Investigator:
          • Hiram Bezerra, MD
        • Contact:
        • Sub-Investigator:
          • Kostas Marmagkiolis, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Gaetano Paone, MD, MHSA
        • Principal Investigator:
          • George Hanzel, MD, FACC
        • Contact:
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Recruiting
        • Cardiovascular Institute of the South
        • Contact:
        • Principal Investigator:
          • Peter Fail, MD, FACC
        • Principal Investigator:
          • Donald Netherland, MD
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
        • Principal Investigator:
          • John Brown III, MD
        • Principal Investigator:
          • Philippe Genereux, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health
        • Principal Investigator:
          • Michael Rinaldi, MD, FACC
        • Principal Investigator:
          • Eric Skipper, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Recruiting
        • Oklahoma Heart Hospital
        • Contact:
        • Principal Investigator:
          • Bruce Cannon, MD
        • Principal Investigator:
          • Naeem Tahirkheli, MD
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital - Memphis
        • Contact:
        • Principal Investigator:
          • Basil M. Paulus, MD
        • Principal Investigator:
          • H. Edward Garret, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Sachin Goel, MD
        • Principal Investigator:
          • Michael Reardon, MD
        • Contact:
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White
        • Contact:
        • Principal Investigator:
          • Timothy George, MD
        • Principal Investigator:
          • Molly Szerlip, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects ≥ 18 years of age.
  2. Subjects symptomatic New York Heart Association (NYHA) II-IV.
  3. Subjects with severe MR as documented by echo.
  4. Subjects who are at high risk for open-heart surgery as documented by the health care professional (e.g., Heart Team consisting of cardiac surgeon and interventional cardiologist in United States).

Abbreviated Exclusion Criteria:

  1. Inability to understand the study or a history of non-compliance with medical advice.
  2. Unwilling or unable to sign the Informed Consent Form (ICF).
  3. History of any cognitive or mental health status that would interfere with study participation.
  4. Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.)).
  5. Female subjects who are pregnant or planning to become pregnant within the study period.
  6. Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
  7. Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
  8. Known hypersensitivity to contrast media that cannot be adequately medicated.
  9. Evidence of current Left Ventricular Ejection Fraction (LVEF) ≤30% (where current is defined as the latest LVEF measurement completed within 90 days prior to the index procedure).
  10. Concurrent medical condition with a life expectancy of less than 12 months.
  11. Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Event
Time Frame: 30 days
Cardiac death, stroke, mitral valve related repeated intervention
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Index procedure completion (Day 0)
Technical Success per MVARC criteria
Index procedure completion (Day 0)
Procedural success
Time Frame: 30 days
Device success and absence of major device or procedure related serious adverse events
30 days
Device success
Time Frame: 30 days
Device Success per MVARC criteria
30 days
Change in MR grade
Time Frame: 30 days
30 days

Collaborators and Investigators

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

Sponsor

4C Medical Technologies, Inc.

Investigators

  • Principal Investigator: Vinayak Bapat, MD, Allina Health System
  • Principal Investigator: Philippe Généreux, MD, Morristown Medical Center

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)

December 4, 2019

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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