TTVR Early Feasibility Study

Tricuspid Regurgitation Clinical Trial

Official title:

The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04433065
• Other study ID #: MDT20009TMV003
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

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