Actively Recruiting
TTVR Early Feasibility Study
Led by Medtronic Cardiovascular · Updated on 2026-03-09
150
Participants Needed
20
Research Sites
562 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
CONDITIONS
Official Title
TTVR Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is symptomatic despite medical therapy, including diuretics, and is a candidate for bioprosthetic tricuspid valve replacement
- Determined by the Heart Team to be at intermediate or greater risk of mortality with tricuspid valve surgery
- Severe symptomatic primary and/or secondary tricuspid regurgitation confirmed by echocardiography
- New York Heart Association (NYHA) Function Class II or greater
- Anatomically suitable for the Intrepid TTVR delivery system via transfemoral access
- Agreement from patient and physician to attend all post-procedure follow-up visits
- Meets legal minimum age to provide informed consent based on local regulations
You will not qualify if you...
- Life expectancy less than 24 months due to non-cardiac conditions
- Anatomic contraindications to the Intrepid TTVR device (e.g., annular dimensions)
- Presence of intracardiac mass or thrombus in the inferior vena cava or femoral veins
- Implanted venous stents or inferior vena cava filter, or congenital IVC abnormalities preventing transfemoral access
- Severe right ventricular dysfunction shown by echocardiogram
- Left ventricular ejection fraction below 30% within 30 days before procedure
- Need for urgent or emergency surgery
- Untreated significant coronary artery disease requiring revascularization
- Carcinoid tricuspid regurgitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
California Pacific Medical Center
San Francisco, California, United States, 94115
Actively Recruiting
5
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
6
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
7
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
9
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
10
Providence Saint Patrick Hospital
Missoula, Montana, United States, 59802
Actively Recruiting
11
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
12
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
13
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
14
The Christ Hospital
Cincinnati, Ohio, United States, 45242
Actively Recruiting
15
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
16
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
17
Oregon Health & Science University Hospital
Portland, Oregon, United States, 97239
Actively Recruiting
18
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, United States, 17101
Actively Recruiting
19
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
20
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, United States, 53125
Actively Recruiting
Research Team
A
Abbey Foote
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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