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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
4C Medical Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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