RECRUITING

TTVR Early Feasibility Study

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-10-20

Study Completion:2031-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04433065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sarah Brown

CONTACT

7075917775

rs.tricuspidclinical@medtronic.com

Lynnett Stahl

CONTACT

rs.tricuspidclinical@medtronic.com

Study Locations (Sites)

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

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

The Mount Sinai Hospital

New York, New York, 10029

United States

Columbia University Medical Center/NYPH

New York, New York, 10032

United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, 17101

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Aurora St. Lukes Medical Center

Milwaukee, Wisconsin, 53125

United States

Collaborators and Investigators

Sponsor: Medtronic Cardiovascular

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-20

Study Completion Date2031-07-30

Study Record Updates

Study Start Date2020-10-20

Study Completion Date2031-07-30

Terms related to this study

Additional Relevant MeSH Terms

Tricuspid Regurgitation