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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).
Primary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV) | Subjects will receive either a Medtronic TAV or Edwards TAV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic TAV | Device | Medtronic TAV where commercially available |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room) | (VARC) 3 technical success (at exit from procedure room) | Time of procedure |
| VARC 3 30-day device success |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes patients with symptomatic heart disease due to BVF affecting TAVs and requiring redo TAVR.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RESTORE Study Clinical Team | Contact | 763 514 4000 | RS.RESTORESTUDY@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Fontana, MD | Los Robles Regional Medical Center | Study Chair |
| Guilherme Attizzani, MD | UH, Cleveland Medical Center | Principal Investigator |
| Basel Ramlawi |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Edwards TAV | Device | Edwards TAV where commercially available. |
|
30-day device success
| 30-Day |
| VARC 3 30-day early safety | 30-day early safety | 30-Day |
| Peak and mean invasive gradient post-procedure | Peak and mean invasive gradient will be measured in mmHg | Time of procedure |
| In-hospital clinical outcomes | 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 | 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 | 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 | 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 | 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 | Evaluate coronary accessibility | Up to 30 days |
| New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter | 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 | 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 | QoL: EQ5D assessment | At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years. |
| Lankenau Heart Institute |
| Principal Investigator |
| Abrazo Arizona Heart Hospital | Recruiting | Phoenix | Arizona | 85016 | United States |
|
| Tucson Medical Center | Recruiting | Tucson | Arizona | 85712 | United States |
|
| Kaiser Permanente Los Angeles Medical Center | Recruiting | Los Angeles | California | 90027 | United States |
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| Sutter Heatlh | Recruiting | Sacramento | California | 95816 | United States |
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| Kaiser Permanente Northern California | Recruiting | Sacramento | California | 95825 | United States |
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| Stanford Hospital & Clinics | Recruiting | Stanford | California | 94305 | United States |
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| Los Robles Regional Medical Center | Recruiting | Thousand Oaks | California | 91360 | United States |
|
| Medical Center of the Rockies | Recruiting | Loveland | Colorado | 80538 | United States |
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| Hartford Hospital | Recruiting | Hartford | Connecticut | 06106 | United States |
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| Yale New Haven Hospital | Recruiting | New Haven | Connecticut | 05610 | United States |
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| MedStar Washington Medical Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
|
| Morton Plant Hospital | Recruiting | Clearwater | Florida | 33756 | United States |
|
| HealthPark Medical Center, Lee Memorial Health | Recruiting | Fort Myers | Florida | 33908 | United States |
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| Orlando Health/Orlando Regional Medical Center | Recruiting | Orlando | Florida | 32806 | United States |
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| Tampa General/USF | Recruiting | Tampa | Florida | 33606 | United States |
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| Parkview Health | Recruiting | Fort Wayne | Indiana | 46845 | United States |
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| Saint Vincent Heart Center of Indiana | Recruiting | Indianapolis | Indiana | 46290 | United States |
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| MercyOne Iowa Heart Center | Recruiting | Des Moines | Iowa | 50314 | United States |
|
| University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
|
| The University of Kansas | Recruiting | Kansas City | Kansas | 66103 | United States |
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| Ascension Via Christi St. Francis | Recruiting | Wichita | Kansas | 67214 | United States |
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| Maine Medical Center | Recruiting | Portland | Maine | 04102 | United States |
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| Medstar Union Memorial Hospital | Recruiting | Baltimore | Maryland | 21218 | United States |
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| The Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02135 | United States |
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| University of Michigan Health | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Henry Ford Hospital | Recruiting | Detroit | Michigan | 48202 | United States |
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| Corewell Health (Spectrum) | Recruiting | Grand Rapids | Michigan | 49503 | United States |
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| Abbott Northwestern/Minneapolis Heart | Recruiting | Minneapolis | Minnesota | 55407 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| CentraCare Heart and Vascular Center | Recruiting | Saint Cloud | Minnesota | 56303 | United States |
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| St. Luke's Hospital of Kansas City | Recruiting | Kansas City | Missouri | 64111 | United States |
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| Providence Saint Patrick Hospital | Recruiting | Missoula | Montana | 59802 | United States |
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| Dartmouth-Hitchcock Medical Center | Recruiting | Lebanon | New Hampshire | 03756 | United States |
|
| Catholic Medical Center | Recruiting | Manchester | New Hampshire | 03102 | United States |
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| Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
|
| The Valley Hospital | Recruiting | Paramus | New Jersey | 07652 | United States |
|
| Buffalo General Medical Center | Recruiting | Buffalo | New York | 14203 | United States |
|
| Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
|
| NYU Langone Medical Center | Recruiting | New York | New York | 10016 | United States |
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| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| Saint Francis Hospital | Recruiting | Roslyn | New York | 11576 | United States |
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| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
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| Astrium Health Wake Forest Baptist Medical Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| The Christ Hospital | Recruiting | Cincinnati | Ohio | 45219 | United States |
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| University Hospitals of Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| OhioHealth Riverside Methodist Hospital | Recruiting | Columbus | Ohio | 43214 | United States |
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| Oklahoma Heart Hospital | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
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| Providence Saint Vincent Medical Center | Recruiting | Portland | Oregon | 97225 | United States |
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| Lehigh Valley Hospital | Recruiting | Allentown | Pennsylvania | 18103 | United States |
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| UPMC Pinnacle | Recruiting | Mechanicsburg | Pennsylvania | 17050 | United States |
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| Allegheny General Hospital | Recruiting | Pittsburgh | Pennsylvania | 15212 | United States |
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| UPMC Presbyterian | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Lankenau Medical Center | Recruiting | Wynnewood | Pennsylvania | 19096 | United States |
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| TriStar Centennial Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| St. Thomas West Hospital | Recruiting | Nashville | Tennessee | 37205 | United States |
|
| Ascension Seton Medical Center Austin | Recruiting | Austin | Texas | 78705 | United States |
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| Heart Hospital of Austin | Recruiting | Austin | Texas | 78705 | United States |
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| Baylor Saint Luke's (The Texas Heart Institute) | Recruiting | Houston | Texas | 77030 | United States |
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| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77479 | United States |
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| Methodist Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
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| University of Vermont Medical Center | Recruiting | Burlington | Vermont | 05401 | United States |
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| University of Virginia Medical Center | Recruiting | Charlottesville | Virginia | 22908 | United States |
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| Inova Fairfax Hospital | Recruiting | Falls Church | Virginia | 22042 | United States |
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| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Providence Heart Institute (Providence Sacred Heart) | Recruiting | Spokane | Washington | 99204 | United States |
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| Aurora St. Lukes Medical Center | Recruiting | Milwaukee | Wisconsin | 53215 | United States |
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| Froedtert Hospital | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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