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: * 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
Study Type
OBSERVATIONAL
Enrollment
225
Medtronic TAV where commercially available
Edwards TAV where commercially available.
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
Time frame: 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
Time frame: Late (1-year)
Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room)
(VARC) 3 technical success (at exit from procedure room)
Time frame: Time of procedure
VARC 3 30-day device success
30-day device success
Time frame: 30-Day
VARC 3 30-day early safety
30-day early safety
Time frame: 30-Day
Peak and mean invasive gradient post-procedure
Peak and mean invasive gradient will be measured in mmHg
Time frame: 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.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGAbrazo Arizona Heart Hospital
Phoenix, Arizona, United States
RECRUITINGTucson Medical Center
Tucson, Arizona, United States
RECRUITINGKaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
RECRUITINGSutter Heatlh
Sacramento, California, United States
RECRUITINGKaiser Permanente Northern California
Sacramento, California, United States
RECRUITINGStanford Hospital & Clinics
Stanford, California, United States
RECRUITINGLos Robles Regional Medical Center
Thousand Oaks, California, United States
RECRUITINGMedical Center of the Rockies
Loveland, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITING...and 60 more locations
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years.