Clinical trial NCT06777368: REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Official title: REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2025-01-15
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.

Brief 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).

Detailed description: Primary Objectives:

* To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs
* To determine the factors which are associated with the acute and long-term outcomes of redo TAVR

Eligibility criteria: 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 outcomes:
measure: Primary Outcome Measure
timeFrame: Early (30-days)
measure: Primary Outcome Measure
timeFrame: Late (1-year)
Secondary outcomes:
measure: Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)
timeFrame: Time of procedure
measure: VARC 3 30-day device success
timeFrame: 30-Day
measure: VARC 3 30-day early safety
timeFrame: 30-Day
measure: Peak and mean invasive gradient post-procedure
timeFrame: Time of procedure
measure: In-hospital clinical outcomes
timeFrame: Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
measure: Clinical outcomes at 30 days, 1-year, and annually thereafter
timeFrame: 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
measure: Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit
timeFrame: 5 year
measure: Bioprosthetic Valve Failure (BVF) at the final required follow-up visit
timeFrame: Through study completion or Up to 5-years
measure: Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter
timeFrame: After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
measure: Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days
timeFrame: Up to 30 days
measure: New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter
timeFrame: After the procedure and prior to discharge from the hospital, at 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
measure: KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter
timeFrame: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
measure: EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter
timeFrame: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Abrazo Arizona Heart Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Heatlh
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Morton Plant Hospital
state: Florida
city: Fort Myers
country: United States
facility: HealthPark Medical Center, Lee Memorial Health
state: Florida
city: Orlando
country: United States
facility: Orlando Health/Orlando Regional Medical Center
state: Florida
city: Des Moines
country: United States
facility: MercyOne Iowa Heart Center
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern/Minneapolis Heart
state: Minnesota
city: Missoula
country: United States
facility: Providence Saint Patrick Hospital
state: Montana
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Buffalo General Medical Center
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: Roslyn
country: United States
facility: Saint Francis Hospital
state: New York
city: Winston-Salem
country: United States
facility: Astrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Spokane
country: United States
facility: Providence Heart Institute (Providence Sacred Heart)
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Lukes Medical Center
state: Wisconsin
Study officials:
affiliation: Los Robles Regional Medical Center
name: Gregory Fontana, MD
role: STUDY_CHAIR
affiliation: UH, Cleveland Medical Center
name: Guilherme Attizzani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lankenau Heart Institute
name: Basel Ramlawi
role: PRINCIPAL_INVESTIGATOR
References: