AltaValve Early Feasibility Study Protocol
1 other identifier
interventional
15
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedStudy Start
First participant enrolled
December 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 1, 2023
August 1, 2023
5.7 years
June 21, 2019
August 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiac Event
Cardiac death, stroke, mitral valve related repeated intervention
30 days
Secondary Outcomes (4)
Technical success
Index procedure completion (Day 0)
Procedural success
30 days
Device success
30 days
Change in MR grade
30 days
Interventions
Transcatheter Mitral Valve Replacement
Eligibility Criteria
You may qualify if:
- Subjects ≥ 18 years of age.
- Subjects symptomatic New York Heart Association (NYHA) II-IV.
- Subjects with severe MR as documented by echo.
- 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).
You may not qualify if:
- Inability to understand the study or a history of non-compliance with medical advice.
- Unwilling or unable to sign the Informed Consent Form (ICF).
- History of any cognitive or mental health status that would interfere with study participation.
- 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.)).
- Female subjects who are pregnant or planning to become pregnant within the study period.
- Known hypersensitivity or contraindication to aspirin, heparin, or Warfarin without adequate alternative medications.
- Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
- Known hypersensitivity to contrast media that cannot be adequately medicated.
- 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).
- Concurrent medical condition with a life expectancy of less than 12 months.
- Prior mitral valve repair/replacement (excluding prior surgical mitral valve repair, annuloplasty, or MitraClip not interfering with AltaValve placement).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Tucson Medical Center
Tucson, Arizona, 85712, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30308, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Atrium Health
Charlotte, North Carolina, 28203, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73135, United States
Baptist Memorial Hospital - Memphis
Memphis, Tennessee, 38120, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Baylor Scott & White
Plano, Texas, 75093, United States
Related Publications (1)
Genereux P, Wrobel K, Ninios V, Grygier M, Tahirkheli N, Sorajja P, Rinaldi MJ, Reardon MJ, Zembala MO, Bezerra HG, Waggoner TE, Giustino G, Waksman R, Grayburn P, Bapat V. 6-Month Outcomes of a Supra-Annular Transcatheter Mitral Valve Replacement: An Early Feasibility Study. JACC Cardiovasc Interv. 2025 Nov 10;18(21):2584-2592. doi: 10.1016/j.jcin.2025.08.040.
PMID: 41224388DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Genereux, MD
Morristown Medical Center
- PRINCIPAL INVESTIGATOR
Vinayak Bapat, MD
Allina Health System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 25, 2019
Study Start
December 4, 2019
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
September 1, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share