Actively Recruiting
AltaValve Pivotal Trial
Led by 4C Medical Technologies, Inc. · Updated on 2025-05-02
450
Participants Needed
29
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
CONDITIONS
Official Title
AltaValve Pivotal Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- Symptomatic New York Heart Association (NYHA) class II-IV
- Moderate-to-severe or severe mitral regurgitation despite optimal guideline-directed medical therapy as confirmed by independent Echo Core Lab
- Unsuitable for surgery and transcatheter edge-to-edge repair as determined by local site Heart Team
You will not qualify if you...
- Inability to understand the trial or history of non-compliance with medical advice
- Inability to provide signed informed consent
- History of cognitive or mental health issues interfering with trial participation
- Currently enrolled in other pre-approval investigational trials that may interfere with study endpoints
- Female subjects who are pregnant or planning pregnancy during the trial
- Known hypersensitivity or contraindication to heparin or warfarin without alternatives
- Known hypersensitivity to nitinol (nickel allergy) not adequately medicated
- Known hypersensitivity to contrast media not adequately medicated
- Left ventricular ejection fraction 64 25%
- Medical conditions limiting life expectancy to less than 12 months
- Transcatheter aortic repair or replacement within 90 days before procedure
- Percutaneous coronary intervention within 90 days before procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Dignity Health; St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85032
Actively Recruiting
3
TMC Healthcare
Tucson, Arizona, United States, 85712
Actively Recruiting
4
Sutter Bay Hospitals
San Francisco, California, United States, 94107
Actively Recruiting
5
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States, 91360
Actively Recruiting
6
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
7
MedStar Health Research Institute, Inc.
Columbia, Maryland, United States, 21044
Actively Recruiting
8
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
9
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
12
AHS Hospital Corp.
Morristown, New Jersey, United States, 07960
Actively Recruiting
13
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
14
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
15
The Charlotte-Mecklenburg Hospital; Atrium Health
Charlotte, North Carolina, United States, 28203
Actively Recruiting
16
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
17
South Oklahoma Heart Research, LLC.
Oklahoma City, Oklahoma, United States, 73135
Actively Recruiting
18
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
19
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
20
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
21
Universitatsklinikum Bonn
Bonn, Germany
Actively Recruiting
22
University Hospital Cologne - Heart Center
Cologne, Germany
Actively Recruiting
23
Cardiac Research GmbH; St.-Johannes-Hospital Dortmund
Dortmund, Germany
Actively Recruiting
24
Heart Center Trier
Trier, Germany
Actively Recruiting
25
Onassis Cardiac Surgery Center
Athens, Greece
Actively Recruiting
26
Interbalkan Medical Center of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
27
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
28
Fundación para la investigación biomédica del hospital clínico San Carlos
Madrid, Spain
Actively Recruiting
29
Hospital Álvaro Cunqueiro
Vigo, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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