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AltaValve Early Feasibility Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997305
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
4C Medical Technologies, Inc.

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

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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 : October 2020
Estimated Study Completion Date : September 2025

Intervention Details:
  • Device: AltaValve
    Transcatheter Mitral Valve Replacement


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: 30 days ]
    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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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) ≤25% (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).

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: Britney Kotaska +1-612-428-7130 altavalveEFS@4cmed.com
Contact: Erika Youngstrom

Locations
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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         
Principal Investigator: Christian Shultz, MD         
United States, Illinois
Prairie Heart Institute Recruiting
Springfield, Illinois, United States, 62769
Contact: Stephanie Hudson    217-492-9100 ext 29151    shudson@prairieresearch.com   
Contact: Melissa McHugh, MS    217-492-9100 ext 29110    MMchugh@prairieresearch.com   
Principal Investigator: Nilesh Goswami, MD         
Principal Investigator: Jeffrey Christy, 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         
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: James Slater, MD         
United States, North Carolina
Atrium Health Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Maria Duncan, RN, MSN    704-355-4796    maria.duncan1@atriumhealth.org   
Principal Investigator: Michael Rinaldi, MD         
Principal Investigator: Eric Skipper, MD         
NC Heart & Vascular Research Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Nicol Trader    919-787-5380 ext 1018564    caroline.trader@unchealth.unc.edu   
Principal Investigator: Willis Wu, MD         
Principal Investigator: Curtis Anderson, 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: Michael Reardon, MD         
Principal Investigator: Neal Kleinman, MD         
Canada, Quebec
Montreal Heart Institute Not yet recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Cyntia Pennestri    514-376-3330 ext 2236    cyntia.pennestri@icm-mhi.org   
Principal Investigator: Anita Asgar, MD         
Principal Investigator: Michel Pellerin, MD         
Université Laval Not yet recruiting
Quebec City, Quebec, Canada, G1V 4G2
Contact: Shriley Baril    418-656-8711 ext 4129    shirley.baril@criucpq.ulaval.ca   
Principal Investigator: Josep Rodes-Cabau, MD         
Principal Investigator: Francois Dagenais, MD         
Japan
Shonan Kamakura General Hosptial Active, not recruiting
Kamakura, Kanagawa, Japan, 247-8533
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 Columbia University
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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: June 12, 2020
Last Verified: June 2020
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