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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04433065
Other study ID # MDT20009TMV003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2020
Est. completion date July 30, 2031

Study information

Verified date April 2024
Source Medtronic Cardiovascular
Contact Sarah Brown
Phone 7075917775
Email rs.tricuspidclinical@medtronic.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Multi-center, prospective, non-randomized, investigational, and pre-market.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date July 30, 2031
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intrepid™ TTVR System
Device: Intrepid™ TTVR System

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Emory University Hospital Midtown Atlanta Georgia
United States University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama
United States Montefiore Medical Center Bronx New York
United States OhioHealth Riverside Methodist Hospital Columbus Ohio
United States UPMC Pinnacle Harrisburg Campus Harrisburg Pennsylvania
United States Houston Methodist Hospital Houston Texas
United States Cedars Sinai Medical Center Los Angeles California
United States Aurora St. Lukes Medical Center Milwaukee Wisconsin
United States Abbott Northwestern Hospital Minneapolis Minnesota
United States Columbia University Medical Center/NYPH New York New York
United States The Mount Sinai Hospital New York New York
United States Abrazo Arizona Heart Hospital Phoenix Arizona
United States Oregon Health & Science University Portland Oregon
United States California Pacific Medical Center San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of implant or delivery related serious adverse events Rate of implant or delivery related serious adverse events Through 30 days post-procedure
Secondary Successful access, delivery of implant, and retrieval of the delivery system assessed by definitions per Mitral Valve Academic Research Consortium (MVARC) For procedural success to be present, device success must have been achieved without major clinical complications as detailed per clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement (part 2: endpoint definitions) During Procedure
Secondary Change in TR Grade from baseline Change in TR Grade from baseline Through 30 days post-procedure
Secondary Rate of no significant TV stenosis Rate of no significant TV stenosis Through 30 days post-procedure
Secondary Change in NYHA Class from baseline Change in NYHA Class from baseline Through 30 days post-procedure
See also
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Enrolling by invitation NCT05825898 - Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Completed NCT05836493 - Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Enrolling by invitation NCT06033274 - Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Recruiting NCT05671640 - Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT06027307 - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Phase 3
Terminated NCT04665583 - Prehab Prior to Undergoing Tricuspid Intervention
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Not yet recruiting NCT05556460 - Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT05667519 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE) N/A
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT05179616 - Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Completed NCT02644616 - The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement Phase 4
Recruiting NCT05328284 - PASCAL for Tricuspid Regurgitation - a European Registry
Completed NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
Recruiting NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement N/A
Completed NCT01093001 - Tricuspid Regurgitation Study Phase 4
Not yet recruiting NCT05173233 - Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System N/A