Early feasibility assessment of a new heart valve replacement system for tricuspid regurgitation

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

This study is testing a new heart valve replacement system to see if it helps people with tricuspid regurgitation who are still having symptoms despite treatment and are not good candidates for traditional surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medtronic Cardiovascular (industry)
• Locations: 20 sites (Birmingham, Alabama and 19 other locations)
• Trial ID: NCT04433065 on ClinicalTrials.gov

What this trial studies

This early feasibility study aims to evaluate the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system, which is designed for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve. The study is multi-center, prospective, non-randomized, and investigational, focusing on patients who are symptomatic despite medical therapy and are at intermediate or greater risk for traditional surgery. Participants will undergo assessments to determine their eligibility based on echocardiographic evaluations and clinical criteria.

Who should consider this trial

Good fit: Ideal candidates are patients with severe symptomatic tricuspid regurgitation who are at intermediate or greater risk for traditional surgery.

Not a fit: Patients who are not symptomatic or who have a low risk of mortality with traditional tricuspid valve surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients suffering from severe tricuspid regurgitation.

How similar studies have performed: Other studies involving transcatheter heart valve technologies have shown promising results, suggesting potential success for this novel approach.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama and 19 other locations

• University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States (RECRUITING)
• Abrazo Arizona Heart Hospital — Phoenix, Arizona, United States (RECRUITING)
• Cedars Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
• California Pacific Medical Center — San Francisco, California, United States (RECRUITING)
• Hartford Hospital — Hartford, Connecticut, United States (RECRUITING)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)
• University of Michigan Health System - University Hospital — Ann Arbor, Michigan, United States (RECRUITING)
• Corewell Health — Grand Rapids, Michigan, United States (RECRUITING)
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (RECRUITING)
• Providence Saint Patrick Hospital — Missoula, Montana, United States (RECRUITING)
• The Mount Sinai Hospital — New York, New York, United States (RECRUITING)
• New York-Presbyterian Hospital Columbia University Medical Center — New York, New York, United States (RECRUITING)
• Montefiore Medical Center — The Bronx, New York, United States (RECRUITING)
• The Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States (RECRUITING)
• Oregon Health & Science University Hospital — Portland, Oregon, United States (RECRUITING)
• UPMC Pinnacle Harrisburg Campus — Harrisburg, Pennsylvania, United States (RECRUITING)
• Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
• Aurora Saint Lukes Medical Center — Milwaukee, Wisconsin, United States (RECRUITING)

Study contacts

• Study coordinator: Abbey Foote

Conditions: Tricuspid Regurgitation