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REdo tranScatheter aortaklapudskiftning for transkateter aortaklapfejl (RESTORE)

23. september 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Aortastenose

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

225

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 105 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Observationsmodeller: COHORT
Tidsperspektiver: PROSPECTIVE

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte	Intervention / Behandling
Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV) Subjects will receive either a Medtronic TAV or Edwards TAV	Enhed: Medtronic TAV Medtronic TAV where commercially available Enhed: Edwards TAV Edwards TAV where commercially available.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic Cardiovascular

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. februar 2025

Primær færdiggørelse (Anslået)

1. november 2027

Studieafslutning (Anslået)

1. november 2027

Datoer for studieregistrering

Først indsendt

17. december 2024

Først indsendt, der opfyldte QC-kriterier

10. januar 2025

Først opslået (Faktiske)

15. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

MDT23040EVR015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

REdo tranScatheter aortaklapudskiftning for transkateter aortaklapfejl (RESTORE)

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Anslået)

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Prøveudtagningsmetode

Studiebefolkning

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.