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Trial record 1 of 1 for:    AltaValve Early Feasibility Study
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AltaValve Early Feasibility Study Protocol

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ClinicalTrials.gov Identifier: NCT03997305
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : November 17, 2022
Sponsor:
Information provided by (Responsible Party):
4C Medical Technologies, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Mitral Insufficiency Mitral Valve Incompetence Mitral Valve Regurgitation Mitral Incompetence Device: AltaValve Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AltaValve Early Feasibility Study Protocol
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : September 2025
Arms and Interventions
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Intervention Details:
  • Device: AltaValve
    Transcatheter Mitral Valve Replacement

Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Cardiac Event [ Time Frame: 30 days ]
    Cardiac death, stroke, mitral valve related repeated intervention


Secondary Outcome Measures :
  1. Technical success [ Time Frame: Index procedure completion (Day 0) ]
    Technical Success per MVARC criteria

  2. Procedural success [ Time Frame: 30 days ]
    Device success and absence of major device or procedure related serious adverse events

  3. Device success [ Time Frame: 30 days ]
    Device Success per MVARC criteria

  4. Change in MR grade [ Time Frame: 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997305


Contacts
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Contact: Kevin Booth 580-399-3767 AltaValveEFS@4CMed.com

Locations
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United States, California
Los Robles Regional Medical Center Recruiting
Thousand Oaks, California, United States, 91360
Contact: Mane Arabyan    805-796-3746    Mane.Arabyan@hcahealthcare.com   
Principal Investigator: Saibal Kar, MD, FACC, FSCAI         
Principal Investigator: Gregory Fontana, MD, FACS, FACC         
United States, District of Columbia
MedStar Washington Hospital Recruiting
Washington, District of Columbia, United States, 20010
Contact: Erin C Collins, MPH    202-877-6622    erin.c.collins@medstar.net   
Principal Investigator: Ron Waksman, MD, FACS         
Principal Investigator: Christian Shults, MD, FACS         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact: Elizabeth Charles    404-686-1249    elizabeth.z.charles@emory.edu   
Principal Investigator: Gaetano Paone, MD, MHSA         
Principal Investigator: George Hanzel, MD, FACC         
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Jennifer Aucoin, LPN       Jennifer.Aucoin@cardio.com   
Principal Investigator: Peter Fail, MD, FACC         
Principal Investigator: Donald Netherland, MD         
Principal Investigator: Stephen Ball, MD         
United States, Minnesota
CentraCare Hearth and Vascular Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Peggy Dahl, RN    320-251-2700 ext 52187    dahlp@centracare.com   
Contact: Jennifer Humbert, BSN    320-251-2800 ext 57560    humbertj@centracare.com   
Principal Investigator: Thom Dahle, MD, FACC         
Principal Investigator: Daren Danielson, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Catherine VanZile    201-787-2254    catherine.vanzile@atlantichealth.org   
Principal Investigator: Philippe Genereux, MD         
Principal Investigator: John Brown III, MD         
United States, New York
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago, RN       lyn.santiago@chsli.org   
Principal Investigator: George A Petrossian, MD         
Principal Investigator: Newell B Robinson, MD         
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Bandaa Setliff, RN       bandaa.setliff@atriumhealth.org   
Principal Investigator: Michael Rinaldi, MD, FACC         
Principal Investigator: Eric Skipper, MD         
United States, Ohio
The Lindner Research Center at The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Julianne O'Brien    513-585-1777      
Principal Investigator: Joseph Choo, MD, FACC         
Principal Investigator: J Michael Smith, MD         
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73135
Contact: Julie White    405-628-6865    juliewhite@okheart.com   
Principal Investigator: Bruce Cannon, MD         
Principal Investigator: Naeem Tahirkheli, MD         
United States, Tennessee
Baptist Memorial Hospital - Memphis Recruiting
Memphis, Tennessee, United States, 38120
Contact: Mary Thurmond    901-747-1262    mary@cvsclinic.com   
Principal Investigator: H. Edward Grant Jr., MD         
Principal Investigator: Basil M. Paulus, MD         
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Lisa Green, RN, BSN    713-441-3629    lmgreen@houstonmethodist.org   
Principal Investigator: Sachin Goel, MD, FACC         
Principal Investigator: Moritz Wyler von Ballmoos, MD, FACC         
Baylor Scott & White Recruiting
Plano, Texas, United States, 75093
Contact: Alexandra Finley    469-814-4235    Alexandra.Finley@BSWHealth.org   
Principal Investigator: Molly Szerlip, MD, FACC, FSCAI         
Principal Investigator: Timothy George, MD         
Sponsors and Collaborators
4C Medical Technologies, Inc.
Investigators
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Principal Investigator: Philippe Genereux, MD Morristown Medical Center
Principal Investigator: Vinayak Bapat, MD Allina Health System
More Information
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Responsible Party: 4C Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03997305    
Other Study ID Numbers: 1890
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by 4C Medical Technologies, Inc.:
Mitral Regurgitation
TMVR
Functional Regurgitation
Degenerative Regurgitation
 Transcathether Mitral Valve Replacement
Primary Regurgitation
Secondary Regurgitation
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases