TTVR Early Feasibility Study
The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
1 other identifier
interventional
150
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Longer than P75 for not_applicable
20 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 4, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 30, 2031
March 9, 2026
March 1, 2026
5.8 years
June 4, 2020
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of implant or delivery related serious adverse events
Rate of implant or delivery related serious adverse events
Through 30 days post-procedure
Secondary Outcomes (4)
Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC)
During Procedure
Change in TR Grade from baseline
Through 30 days post-procedure
Rate of no significant TV stenosis
Through 30 days post-procedure
Change in NYHA Class from baseline
Through 30 days post-procedure
Study Arms (1)
Primary Cohort
EXPERIMENTALDevice: Intrepid TTVR System
Interventions
Eligibility Criteria
You may qualify if:
- Heart Team agrees that patient is deemed symptomatic despite medical therapy (including obligatory diuretic) and a candidate for bioprosthetic tricuspid valve replacement
- Subject is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the local Heart Team
- Subjects with severe symptomatic primary and / or secondary tricuspid regurgitation determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE)
- New York Heart Association (NYHA) Function Class II or greater
- Subject anatomically suitable for the Intrepid TTVR delivery system including transfemoral access
- Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
- Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
You may not qualify if:
- Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
- Anatomic contraindications for Intrepid™ TTVR (e.g., annular dimensions)
- Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
- Implanted with venous stents (iliac and/or femoral) or inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access of delivery system
- Echocardiographic evidence of severe right ventricular dysfunction
- Left ventricular ejection fraction (LVEF) \<30 as measured by resting echocardiogram within 30 days of the Index Procedure
- Need for emergent or urgent surgery
- Untreated clinically significant coronary artery disease requiring revascularization
- Carcinoid tricuspid regurgitation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35233, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, 85016, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
University of Michigan Health System - University Hospital
Ann Arbor, Michigan, 48109, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Providence Saint Patrick Hospital
Missoula, Montana, 59802, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
The Christ Hospital
Cincinnati, Ohio, 45242, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Oregon Health & Science University Hospital
Portland, Oregon, 97239, United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Aurora Saint Lukes Medical Center
Milwaukee, Wisconsin, 53125, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 4, 2020
First Posted
June 16, 2020
Study Start
October 20, 2020
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 30, 2031
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share