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REdo tranScatheter aortic valve replacement for transcatheter aortic valve failuRE (RESTORE)

23. september 2026 oppdatert av: Medtronic Cardiovascular

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).

Studieoversikt

Status

Rekruttering

Forhold

Aortastenose

Intervensjon / Behandling

Detaljert beskrivelse

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

Studietype

Observasjonsmessig

Registrering (Antatt)

225

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: RESTORE Study Clinical Team
Telefonnummer: 763 514 4000
E-post: RS.RESTORESTUDY@medtronic.com

Studiesteder

Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35233
    - Rekruttering
    - University of Alabama at Birmingham
    - Hovedetterforsker:
      
      Mustafa Ahmed, MD
    - Ta kontakt med:
      
      Marissa Waite
- Arizona
  - Phoenix, Arizona, Forente stater, 85016
    - Rekruttering
    - Abrazo Arizona Heart Hospital
    - Hovedetterforsker:
      
      Timothy Byrne, MD
    - Hovedetterforsker:
      
      Merick Kirshner, MD
    - Ta kontakt med:
      
      Jessica Byrne
  - Tucson, Arizona, Forente stater, 85712
    - Tilbaketrukket
    - Tucson Medical Center
- California
  - Los Angeles, California, Forente stater, 90027
    - Rekruttering
    - Kaiser Permanente Los Angeles Medical Center
    - Hovedetterforsker:
      
      Somjot Brar, MD
    - Ta kontakt med:
      
      Jaclyn Cordova
  - Sacramento, California, Forente stater, 95816
    - Rekruttering
    - Sutter Heatlh
    - Hovedetterforsker:
      
      Pei-Hsiu Huang, MD
    - Ta kontakt med:
      
      Jessica McCall
  - Sacramento, California, Forente stater, 95825
    - Rekruttering
    - Kaiser Permanente Northern California
    - Ta kontakt med:
      
      Ann Rose Downing
    - Hovedetterforsker:
      
      Femi Philip, MD
  - Stanford, California, Forente stater, 94305
    - Rekruttering
    - Stanford Hospital & Clinics
    - Hovedetterforsker:
      
      William Fearon, MD
    - Ta kontakt med:
      
      Ayesha Zaina
    - Ta kontakt med:
      
      Anushka Marathe
  - Thousand Oaks, California, Forente stater, 91360
    - Rekruttering
    - Los Robles Regional Medical Center
    - Hovedetterforsker:
      
      Saibal Kar, MD
    - Ta kontakt med:
      
      Mane Arabyan
    - Hovedetterforsker:
      
      Greg Fontana, MD
- Colorado
  - Loveland, Colorado, Forente stater, 80538
    - Rekruttering
    - Medical Center of the Rockies
    - Hovedetterforsker:
      
      Justin Strote, MD
    - Ta kontakt med:
      
      Darcee Robeson
- Connecticut
  - Hartford, Connecticut, Forente stater, 06106
    - Rekruttering
    - Hartford Hospital
    - Hovedetterforsker:
      
      Robert Hagberg, MD
    - Ta kontakt med:
      
      Jadwiga Jerman
    - Hovedetterforsker:
      
      Sarfaraz Memon, MD
  - New Haven, Connecticut, Forente stater, 05610
    - Rekruttering
    - Yale New Haven Hospital
    - Hovedetterforsker:
      
      John Forrest, MD
    - Ta kontakt med:
      
      Scott Ardito
- District of Columbia
  - Washington D.C., District of Columbia, Forente stater, 20010
    - Rekruttering
    - MedStar Washington Medical Center
    - Hovedetterforsker:
      
      Ron Waksman, MD
    - Ta kontakt med:
      
      Erin Collins
- Florida
  - Clearwater, Florida, Forente stater, 33756
    - Rekruttering
    - Morton Plant Hospital
    - Hovedetterforsker:
      
      Joshua Rovin, MD
    - Ta kontakt med:
      
      Sue Fisher
    - Hovedetterforsker:
      
      Jayendrakumar Patel, MD
  - Fort Myers, Florida, Forente stater, 33908
    - Rekruttering
    - HealthPark Medical Center, Lee Memorial Health
    - Hovedetterforsker:
      
      David Cervantes, MD
    - Ta kontakt med:
      
      Michelle Deckard
  - Orlando, Florida, Forente stater, 32806
    - Rekruttering
    - Orlando Health/Orlando Regional Medical Center
    - Ta kontakt med:
      
      George Ngo
    - Hovedetterforsker:
      
      Joel Garcia-Fernandez, MD
  - Tampa, Florida, Forente stater, 33606
    - Rekruttering
    - Tampa General/USF
    - Hovedetterforsker:
      
      Hiram Bezerra, MD
    - Ta kontakt med:
      
      Mia Eifrid
- Indiana
  - Fort Wayne, Indiana, Forente stater, 46845
    - Rekruttering
    - Parkview Health
    - Hovedetterforsker:
      
      Roy Robertson, MD
    - Ta kontakt med:
      
      Tressa Brunner
  - Indianapolis, Indiana, Forente stater, 46290
    - Rekruttering
    - Saint Vincent Heart Center of Indiana
    - Hovedetterforsker:
      
      Ezequiel Munoz, MD
    - Ta kontakt med:
      
      Cari Fekete
- Iowa
  - Des Moines, Iowa, Forente stater, 50314
    - Rekruttering
    - MercyOne Iowa Heart Center
    - Hovedetterforsker:
      
      David McAllister, MD
    - Ta kontakt med:
      
      Kendra Tuttle
  - Iowa City, Iowa, Forente stater, 52242
    - Rekruttering
    - University of Iowa Hospitals and Clinics
    - Ta kontakt med:
      
      Amy Black
    - Ta kontakt med:
      
      Amy Olinger
    - Hovedetterforsker:
      
      Philip Horwitz, MD
- Kansas
  - Kansas City, Kansas, Forente stater, 66103
    - Rekruttering
    - The University of Kansas
    - Ta kontakt med:
      
      Amy Gorsuch
    - Hovedetterforsker:
      
      George (Trip) Zorn, MD
  - Wichita, Kansas, Forente stater, 67214
    - Rekruttering
    - Ascension Via Christi St. Francis
    - Hovedetterforsker:
      
      Bassem Chehab, MD
    - Hovedetterforsker:
      
      Brett Grizzell, MD
    - Ta kontakt med:
      
      Meredith Thunberg
- Maine
  - Portland, Maine, Forente stater, 04102
    - Rekruttering
    - Maine Medical Center
    - Ta kontakt med:
      
      Joanne Burgess
    - Hovedetterforsker:
      
      David Butzel, MD
- Maryland
  - Baltimore, Maryland, Forente stater, 21287
    - Rekruttering
    - The Johns Hopkins Hospital
    - Hovedetterforsker:
      
      Rani Hasan, MD
    - Ta kontakt med:
      
      Michele Fisher
  - Baltimore, Maryland, Forente stater, 21218
    - Rekruttering
    - Medstar Union Memorial Hospital
    - Hovedetterforsker:
      
      John Wang, MD
    - Ta kontakt med:
      
      Keith Moyer
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02114
    - Rekruttering
    - Massachusetts General Hospital
    - Hovedetterforsker:
      
      Rahul Sakhuja, MD
    - Ta kontakt med:
      
      Joanna Mandinova
  - Boston, Massachusetts, Forente stater, 02135
    - Rekruttering
    - Brigham and Women's Hospital
    - Ta kontakt med:
      
      Sinead Coyle
    - Hovedetterforsker:
      
      Piotr Sobieszczyk, MD
- Michigan
  - Ann Arbor, Michigan, Forente stater, 48109
    - Rekruttering
    - University of Michigan Health
    - Hovedetterforsker:
      
      Stanley Chetcuti, MD
    - Ta kontakt med:
      
      Jessica Frizzell
    - Hovedetterforsker:
      
      Shininchi Fukuhara, MD
  - Detroit, Michigan, Forente stater, 48202
    - Rekruttering
    - Henry Ford Hospital
    - Hovedetterforsker:
      
      Pedro Engel Gonzalez, MD
    - Ta kontakt med:
      
      Emily Ward
  - Grand Rapids, Michigan, Forente stater, 49503
    - Rekruttering
    - Corewell Health (Spectrum)
    - Hovedetterforsker:
      
      William Merhi, MD
    - Hovedetterforsker:
      
      Stephane Leung, MD
    - Ta kontakt med:
      
      Elizabeth Helm
- Minnesota
  - Minneapolis, Minnesota, Forente stater, 55407
    - Rekruttering
    - Abbott Northwestern/Minneapolis Heart
    - Hovedetterforsker:
      
      Paul Sorajja, MD
    - Hovedetterforsker:
      
      Vinayak Bapat, MD
    - Ta kontakt med:
      
      Alexa Hunsinger
  - Rochester, Minnesota, Forente stater, 55905
    - Rekruttering
    - Mayo Clinic
    - Hovedetterforsker:
      
      Mohamad Alkhouli, MD
    - Ta kontakt med:
      
      Tricia Conley
  - Saint Cloud, Minnesota, Forente stater, 56303
    - Rekruttering
    - CentraCare Heart and Vascular Center
    - Hovedetterforsker:
      
      Thom Dahle, MD
    - Ta kontakt med:
      
      Jennifer Humbert
- Missouri
  - Kansas City, Missouri, Forente stater, 64111
    - Rekruttering
    - St. Luke's Hospital of Kansas City
    - Hovedetterforsker:
      
      Chetan Huded, MD
    - Ta kontakt med:
      
      Peggy Owen
- Montana
  - Missoula, Montana, Forente stater, 59802
    - Rekruttering
    - Providence Saint Patrick Hospital
    - Hovedetterforsker:
      
      Michael Reed, MD
    - Ta kontakt med:
      
      Tara Westlie
    - Hovedetterforsker:
      
      Travis Abicht, MD
- New Hampshire
  - Lebanon, New Hampshire, Forente stater, 03756
    - Rekruttering
    - Dartmouth-Hitchcock Medical Center
    - Hovedetterforsker:
      
      Michael Young, MD
    - Ta kontakt med:
      
      Brian Aldrich
  - Manchester, New Hampshire, Forente stater, 03102
    - Rekruttering
    - Catholic Medical Center
    - Ta kontakt med:
      
      Jennifer Driscoll
    - Hovedetterforsker:
      
      Fahad Gilani, MD
- New Jersey
  - Neptune City, New Jersey, Forente stater, 07753
    - Rekruttering
    - Jersey Shore University Medical Center
    - Hovedetterforsker:
      
      Matthew Saybolt, MD
    - Ta kontakt med:
      
      Ann Marie DeToro
  - Paramus, New Jersey, Forente stater, 07652
    - Rekruttering
    - The Valley Hospital
    - Hovedetterforsker:
      
      Rajiv Tayal, MD
    - Ta kontakt med:
      
      Kimberly Michel
- New York
  - Buffalo, New York, Forente stater, 14203
    - Rekruttering
    - Buffalo General Medical Center
    - Hovedetterforsker:
      
      Vijay Iyer, MD
    - Ta kontakt med:
      
      Lindsay Moshides
  - Manhasset, New York, Forente stater, 11030
    - Rekruttering
    - Northwell Health
    - Hovedetterforsker:
      
      Bruce Rutkin, MD
    - Ta kontakt med:
      
      Kristine McGowan
  - New York, New York, Forente stater, 10029
    - Rekruttering
    - Mount Sinai Hospital
    - Hovedetterforsker:
      
      Samin Sharma, MD
    - Ta kontakt med:
      
      Mercedes Morales Castro
  - New York, New York, Forente stater, 10016
    - Rekruttering
    - NYU Langone Medical Center
    - Ta kontakt med:
      
      Patricia Kozikowski
    - Hovedetterforsker:
      
      Mathew Williams, MD
  - Roslyn, New York, Forente stater, 11576
    - Rekruttering
    - Saint Francis Hospital
    - Hovedetterforsker:
      
      George Petrossian, MD
    - Hovedetterforsker:
      
      Newell Robinson, MD
    - Ta kontakt med:
      
      Joan Jennings
  - The Bronx, New York, Forente stater, 10467
    - Rekruttering
    - Montefiore Medical Center
    - Hovedetterforsker:
      
      Mohamed Azeem Latib, MD
    - Ta kontakt med:
      
      Tammy Rodriguez Guzman
- North Carolina
  - Winston-Salem, North Carolina, Forente stater, 27157
    - Rekruttering
    - Astrium Health Wake Forest Baptist Medical Center
    - Ta kontakt med:
      
      Hollie B Davis
    - Hovedetterforsker:
      
      Peter Belford, MD
    - Hovedetterforsker:
      
      Edward Kincaid, MD
- Ohio
  - Cincinnati, Ohio, Forente stater, 45219
    - Rekruttering
    - The Christ Hospital
    - Hovedetterforsker:
      
      Puvi Seshiah, MD
    - Ta kontakt med:
      
      Amanda Sears
  - Cleveland, Ohio, Forente stater, 44106
    - Rekruttering
    - University Hospitals of Cleveland Medical Center
    - Hovedetterforsker:
      
      Guilherme Attizzani, MD
    - Ta kontakt med:
      
      Nisreen Zueiter
    - Hovedetterforsker:
      
      Cristian Baeza, MD
  - Columbus, Ohio, Forente stater, 43214
    - Rekruttering
    - OhioHealth Riverside Methodist Hospital
    - Ta kontakt med:
      
      Kailee Brooks
    - Hovedetterforsker:
      
      Laura Flannery, MD
- Oklahoma
  - Oklahoma City, Oklahoma, Forente stater, 73120
    - Rekruttering
    - Oklahoma Heart Hospital
    - Hovedetterforsker:
      
      Mohammad Ghani, MD
    - Ta kontakt med:
      
      Debbie Schommer
- Oregon
  - Portland, Oregon, Forente stater, 97225
    - Rekruttering
    - Providence Saint Vincent Medical Center
    - Hovedetterforsker:
      
      Brandon Jones, MD
    - Ta kontakt med:
      
      Angela Redd
- Pennsylvania
  - Allentown, Pennsylvania, Forente stater, 18103
    - Rekruttering
    - Lehigh Valley Hospital
    - Ta kontakt med:
      
      Traci Eichelberger
    - Hovedetterforsker:
      
      Dzanan Ramic, MD
  - Mechanicsburg, Pennsylvania, Forente stater, 17050
    - Rekruttering
    - UPMC Pinnacle
    - Ta kontakt med:
      
      Olivia Vehabovic
    - Hovedetterforsker:
      
      Hemal Gada
  - Pittsburgh, Pennsylvania, Forente stater, 15212
    - Rekruttering
    - Allegheny General Hospital
    - Ta kontakt med:
      
      Tracy Spirk
    - Hovedetterforsker:
      
      Ramzi Khalil, MD
  - Pittsburgh, Pennsylvania, Forente stater, 15213
    - Rekruttering
    - UPMC Presbyterian
    - Hovedetterforsker:
      
      Ibrahim Sultan, MD
    - Ta kontakt med:
      
      Stephanie Shearer
    - Hovedetterforsker:
      
      Dustin Kliner, MD
  - Wynnewood, Pennsylvania, Forente stater, 19096
    - Rekruttering
    - Lankenau Medical Center
    - Hovedetterforsker:
      
      Basel Ramlawi, MD
    - Ta kontakt med:
      
      Eunita Chandardat
- Tennessee
  - Nashville, Tennessee, Forente stater, 37203
    - Rekruttering
    - TriStar Centennial Medical Center
    - Hovedetterforsker:
      
      Andrew Goodman, MD
    - Ta kontakt med:
      
      Anna Grace Monroe
  - Nashville, Tennessee, Forente stater, 37205
    - Rekruttering
    - St. Thomas West Hospital
    - Ta kontakt med:
      
      Gabriel Bryant
    - Hovedetterforsker:
      
      Michael Andrew Morse, MD
- Texas
  - Austin, Texas, Forente stater, 78705
    - Rekruttering
    - Ascension Seton Medical Center Austin
    - Hovedetterforsker:
      
      Mark Pirwitz, MD
    - Ta kontakt med:
      
      Madeline Gleason
  - Austin, Texas, Forente stater, 78705
    - Rekruttering
    - Heart Hospital of Austin
    - Ta kontakt med:
      
      Alana Rice
    - Hovedetterforsker:
      
      Frank Zidar, MD
  - Houston, Texas, Forente stater, 77030
    - Rekruttering
    - Houston Methodist Hospital
    - Hovedetterforsker:
      
      Sachin Goel, MD
    - Ta kontakt med:
      
      Tia McGaughy
  - Houston, Texas, Forente stater, 77479
    - Rekruttering
    - University of Texas Health Science Center at Houston
    - Hovedetterforsker:
      
      Abhijeet Dhoble, MD
    - Ta kontakt med:
      
      Matthew Franciskovich
  - Houston, Texas, Forente stater, 77030
    - Rekruttering
    - Baylor Saint Luke's (The Texas Heart Institute)
    - Ta kontakt med:
      
      Sylvia Carranza
    - Hovedetterforsker:
      
      Guilerme Silva, MD
  - San Antonio, Texas, Forente stater, 78229
    - Rekruttering
    - Methodist Hospital
    - Ta kontakt med:
      
      Abigail Eckenrode
    - Hovedetterforsker:
      
      Devang Patel, MD
- Vermont
  - Burlington, Vermont, Forente stater, 05401
    - Rekruttering
    - University of Vermont Medical Center
    - Ta kontakt med:
      
      Amy Henderson
    - Hovedetterforsker:
      
      Harold Dauerman, MD
- Virginia
  - Charlottesville, Virginia, Forente stater, 22908
    - Rekruttering
    - University of Virginia Medical Center
    - Hovedetterforsker:
      
      John Saxon, MD
    - Ta kontakt med:
      
      Erin Orr
  - Falls Church, Virginia, Forente stater, 22042
    - Rekruttering
    - Inova Fairfax Hospital
    - Ta kontakt med:
      
      Diana McLean
    - Hovedetterforsker:
      
      Matthew Sherwood, MD
  - Norfolk, Virginia, Forente stater, 23507
    - Rekruttering
    - Sentara Norfolk General Hospital
    - Hovedetterforsker:
      
      Matthew Summers, MD
    - Ta kontakt med:
      
      Christine Calayo
    - Hovedetterforsker:
      
      Clinton Kemp, MD
- Washington
  - Spokane, Washington, Forente stater, 99204
    - Rekruttering
    - Providence Heart Institute (Providence Sacred Heart)
    - Ta kontakt med:
      
      Nicole McConnell
    - Hovedetterforsker:
      
      Brydan Curtis, MD
- Wisconsin
  - Milwaukee, Wisconsin, Forente stater, 53226
    - Rekruttering
    - Froedtert Hospital
    - Hovedetterforsker:
      
      Saif Anwaruddin, MD
    - Ta kontakt med:
      
      Amy Blair
  - Milwaukee, Wisconsin, Forente stater, 53215
    - Rekruttering
    - Aurora St. Lukes Medical Center
    - Hovedetterforsker:
      
      Tanvir Bajwa, MD
    - Ta kontakt med:
      
      Reva Matz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 105 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: COHORT
Tidsperspektiver: PROSPECTIVE

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort	Intervensjon / Behandling
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV) Subjects will receive either a Medtronic TAV or Edwards TAV	Enhet: Medtronic TAV Medtronic TAV where commercially available Enhet: Edwards TAV Edwards TAV where commercially available.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Primary Outcome Measure Tidsramme: 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	Early (30-days)
Primary Outcome Measure Tidsramme: 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	Late (1-year)

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room) Tidsramme: Time of procedure	(VARC) 3 technical success (at exit from procedure room)	Time of procedure
VARC 3 30-day device success Tidsramme: 30-Day	30-day device success	30-Day
VARC 3 30-day early safety Tidsramme: 30-Day	30-day early safety	30-Day
Peak and mean invasive gradient post-procedure Tidsramme: Time of procedure	Peak and mean invasive gradient will be measured in mmHg	Time of procedure
In-hospital clinical outcomes Tidsramme: Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)	Percentage of all participants with all-cause mortality, all stroke, Myocardial infarction (MI), Coronary artery obstruction, Unplanned Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG), Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, and Valve Thrombosis.	Treatment up to 7 days (or until patient is discharged from the hospital if later than 7 days)
Clinical outcomes at 30 days, 1-year, and annually thereafter Tidsramme: 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.	All-cause mortality, All stroke, Myocardial infarction (MI), Coronary artery obstruction, Bleeding (VARC 3 type 1-4), Major and Minor vascular and access-related complications, Cardiac structural complications, Permanent pacemaker implantation (PPI), Acute Kidney Injury (AKI) stage 1-4, Endocarditis, Valve Thrombosis, Any rehospitalization and re-intervention.	30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit Tidsramme: 5 year	Intrinsic permanent changes to the prosthetic valve, including wear and tear, leaflet disruption, flail leaflet, leaflet fibrosis and/or calcification, or strut fracture or deformation	5 year
Bioprosthetic Valve Failure (BVF) at the final required follow-up visit Tidsramme: Through study completion or Up to 5-years	Any bioprosthetic valve dysfunction associated with clinically expressive criteria (new-onset or worsening symptoms, left ventricle dilation/hypertrophy/dysfunction, or pulmonary hypertension) or irreversible Stage 3 Hemodynamic Valve Deterioration (HVD) or Aortic valve reoperation or re-intervention, or Valve-related death.	Through study completion or Up to 5-years
Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter Tidsramme: 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.	Left ventricular ejection fraction, mean gradient across aortic valve, effective orifice area, effective orifice area index, patient-prosthesis mismatch, Doppler Velocity Index, total aortic regurgitation, paravalvular aortic regurgitation, and transvalvular aortic regurgitation.	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.
Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days Tidsramme: Up to 30 days	Evaluate coronary accessibility	Up to 30 days
New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter Tidsramme: 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.	New York Heart Association (NYHA) classification	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.
KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter Tidsramme: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.	QoL: KCCQ assessment	At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.
EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter Tidsramme: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.	QoL: EQ5D assessment	At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medtronic Cardiovascular

Etterforskere

Hovedetterforsker: Guilherme Attizzani, MD, UH, Cleveland Medical Center
Studiestol: Gregory Fontana, MD, Los Robles Regional Medical Center
Hovedetterforsker: Basel Ramlawi, Lankenau Heart Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. februar 2025

Primær fullføring (Antatt)

1. november 2027

Studiet fullført (Antatt)

1. november 2027

Datoer for studieregistrering

Først innsendt

17. desember 2024

Først innsendt som oppfylte QC-kriteriene

10. januar 2025

Først lagt ut (Faktiske)

15. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

MDT23040EVR015

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

REdo tranScatheter aortic valve replacement for transcatheter aortic valve failuRE (RESTORE)

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Antatt)

Kontakter og plasseringer

Studiekontakt

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Prøvetakingsmetode

Studiepopulasjon

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Etterforskere

Studierekorddatoer

Studer hoveddatoer

Studiestart (Faktiske)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

produkt produsert i og eksportert fra USA