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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham (UAB) Hospital
Recruiting
Birmingham
Arizona
Abrazo Arizona Heart Hospital
Recruiting
Phoenix
California
Cedars Sinai Medical Center
Recruiting
Los Angeles
California Pacific Medical Center
Recruiting
San Francisco
Georgia
Emory University Hospital Midtown
Recruiting
Atlanta
Michigan
University of Michigan
Recruiting
Ann Arbor
Minnesota
Abbott Northwestern Hospital
Recruiting
Minneapolis
New York
Montefiore Medical Center
Recruiting
Bronx
Columbia University Medical Center/NYPH
Recruiting
New York
Ohio
OhioHealth Riverside Methodist Hospital
Recruiting
Columbus
Oregon
Oregon Health & Science University
Recruiting
Portland
Pennsylvania
UPMC Pinnacle Harrisburg Campus
Recruiting
Harrisburg
Texas
Houston Methodist Hospital
Recruiting
Houston
Wisconsin
Aurora St. Lukes Medical Center
Recruiting
Milwaukee
Contact Information
Primary
Sarah Brown
rs.tmvrtransfemoralefs@medtronic.com
7075917775
Backup
Lynnett Stahl
rs.tmvrtransfemoralefs@medtronic.com
Time Frame
Start Date: October 20, 2020
Estimated Completion Date: November 15, 2026
Participants
Target number of participants: 15
Treatments
Experimental: Primary Cohort
Device: Intrepid TTVR System
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular

This content was sourced from clinicaltrials.gov

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