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AltaValve Early Feasibility Study Protocol

Study Description
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
Layout table for study information
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
Outcome Measures
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
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 25, 2019
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE December 4, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		Major Adverse Cardiac Event [ Time Frame: 30 days ]
Cardiac death, stroke, mitral valve related repeated intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2021)
  • Technical success [ Time Frame: Index procedure completion (Day 0) ]
    Technical Success per MVARC criteria
  • Procedural success [ Time Frame: 30 days ]
    Device success and absence of major device or procedure related serious adverse events
  • Device success [ Time Frame: 30 days ]
    Device Success per MVARC criteria
  • Change in MR grade [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • Technical success [ Time Frame: 30 days ]
    Technical Success per MVARC criteria
  • Procedural success [ Time Frame: 30 days ]
    Device success and absence of major device or procedure related serious adverse events
  • Device success [ Time Frame: 30 days ]
    Device Success per MVARC criteria
  • Change in MR grade [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AltaValve Early Feasibility Study Protocol
Official Title  ICMJE AltaValve Early Feasibility Study Protocol
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Regurgitation
  • Mitral Insufficiency
  • Mitral Valve Incompetence
  • Mitral Valve Regurgitation
  • Mitral Incompetence
Intervention  ICMJE Device: AltaValve
Transcatheter Mitral Valve Replacement
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erika Youngstrom +1-612-428-7130 altavalveEFS@4cmed.com
Listed Location Countries  ICMJE United States
Removed Location Countries Canada,   Japan
 
Administrative Information
NCT Number  ICMJE NCT03997305
Other Study ID Numbers  ICMJE 1890
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party 4C Medical Technologies, Inc.
Study Sponsor  ICMJE 4C Medical Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Genereux, MD Morristown Medical Center
Principal Investigator: Vinayak Bapat, MD Allina Health System
PRS Account 4C Medical Technologies, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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