REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE

NCT06777368 · tracked via the Priya Life Science USA tracker

Sponsor

Medtronic Cardiovascular

Phase

Observational

Started

2025-02-06

Last updated

2026-09-24

Condition(s) studied

Aortic Stenosis

Investigational drug(s) / intervention(s)

Medtronic TAVEdwards TAV

Medtronic TAV: Medtronic TAV where commercially available

Edwards TAV: Edwards TAV where commercially available.

Study summary

The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).

Eligibility

Sex

ALL

Min age

18 Years

Max age

105 Years

Healthy volunteers

Inclusion Criteria: * BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR Exclusion Criteria: * BVF due solely to paravalvular regurgitation * Active endocarditis * Untreated acute valve thrombosis * Life-expectancy less than 1-year * Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable * Participating in another study that may influence the outcome of this study

Primary outcome measure(s)

Primary Outcome Measure — Early (30-days)
30-day redo TAVR success defined as correct positioning of a single redo prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index (DVI) ≥0.25, aortic regurgitation (AR) \< moderate), and freedom from all-cause mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device
Primary Outcome Measure — Late (1-year)
a composite endpoint of 1-year freedom from all-cause mortality, all stroke, or any re-hospitalization for valve or redo TAVR procedure-related causes

Trial sites (71)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Recruiting
Abrazo Arizona Heart Hospital	Phoenix	Arizona	Recruiting
Tucson Medical Center	Tucson	Arizona	Withdrawn
Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	Recruiting
Sutter Heatlh	Sacramento	California	Recruiting
Kaiser Permanente Northern California	Sacramento	California	Recruiting
Stanford Hospital & Clinics	Stanford	California	Recruiting
Los Robles Regional Medical Center	Thousand Oaks	California	Recruiting
Medical Center of the Rockies	Loveland	Colorado	Recruiting
Hartford Hospital	Hartford	Connecticut	Recruiting
Yale New Haven Hospital	New Haven	Connecticut	Recruiting
MedStar Washington Medical Center	Washington D.C.	District of Columbia	Recruiting
Morton Plant Hospital	Clearwater	Florida	Recruiting
HealthPark Medical Center, Lee Memorial Health	Fort Myers	Florida	Recruiting
Orlando Health/Orlando Regional Medical Center	Orlando	Florida	Recruiting
Tampa General/USF	Tampa	Florida	Recruiting
Parkview Health	Fort Wayne	Indiana	Recruiting
Saint Vincent Heart Center of Indiana	Indianapolis	Indiana	Recruiting
MercyOne Iowa Heart Center	Des Moines	Iowa	Recruiting
University of Iowa Hospitals and Clinics	Iowa City	Iowa	Recruiting
The University of Kansas	Kansas City	Kansas	Recruiting
Ascension Via Christi St. Francis	Wichita	Kansas	Recruiting
Maine Medical Center	Portland	Maine	Recruiting
Medstar Union Memorial Hospital	Baltimore	Maryland	Recruiting
The Johns Hopkins Hospital	Baltimore	Maryland	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
University of Michigan Health	Ann Arbor	Michigan	Recruiting
Henry Ford Hospital	Detroit	Michigan	Recruiting
Corewell Health (Spectrum)	Grand Rapids	Michigan	Recruiting
Abbott Northwestern/Minneapolis Heart	Minneapolis	Minnesota	Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
CentraCare Heart and Vascular Center	Saint Cloud	Minnesota	Recruiting
St. Luke's Hospital of Kansas City	Kansas City	Missouri	Recruiting
Providence Saint Patrick Hospital	Missoula	Montana	Recruiting
Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	Recruiting
Catholic Medical Center	Manchester	New Hampshire	Recruiting
Jersey Shore University Medical Center	Neptune City	New Jersey	Recruiting
The Valley Hospital	Paramus	New Jersey	Recruiting
Buffalo General Medical Center	Buffalo	New York	Recruiting

+ 31 more sites — see the full list on the official registry below.

More Medtronic Cardiovascular trials in the USA

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients Active, not recruiting

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). Active, not recruiting

Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation Recruiting

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System Active, not recruiting

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial Recruiting

Other trials for the same condition

PARTNER 3 Trial - Aortic Valve-in-Valve Recruiting

ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement Active, not recruiting

CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material Recruiting

Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis Recruiting

STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06777368 on ClinicalTrials.gov ↗ ← All trials in the USA