Aortic Stenosis
Conditions
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
Interventions
DEVICEMedtronic TAV
Medtronic TAV where commercially available
DEVICEEdwards TAV
Edwards TAV where commercially available.
Sponsors
Medtronic Cardiovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 105 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve Academic Research Consortium (VARC) 3 technical success (at exit from procedure room) | Time of procedure | (VARC) 3 technical success (at exit from procedure room) |
| VARC 3 30-day device success | 30-Day | 30-day device success |
| VARC 3 30-day early safety | 30-Day | 30-day early safety |
| Peak and mean invasive gradient post-procedure | Time of procedure | Peak and mean invasive gradient will be measured in mmHg |
| In-hospital clinical outcomes | 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. |
| Clinical outcomes at 30 days, 1-year, and annually thereafter | 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. |
| Bioprosthetic Valve Dysfunction (BVD) at the final required follow-up visit | 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 |
| Bioprosthetic Valve Failure (BVF) at the final required follow-up visit | 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. |
| Echocardiographic assessment pre-discharge or at 30 days, 1-year, and annually thereafter | 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. |
| Evaluate coronary accessibility (e.g., commissural alignment, valve to valve alignment, etc.) based on Computed Tomography (CT) at either pre-discharge or 30 days | Up to 30 days | Evaluate coronary accessibility |
| New York Heart Association (NYHA) classification at pre-discharge, 30 days, 1-year, and annually thereafter | 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 |
| KCCQ Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter | At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years. | QoL: KCCQ assessment |
| EQ5D Quality of life (QoL) assessments at 30 days, 1-year, and annually thereafter | At 30 days, at 1 year, at 2 years, at 3 years, at 4 years, and at 5 years. | QoL: EQ5D assessment |
Countries
United States
Contacts
CONTACTRESTORE Study Clinical Team
STUDY_CHAIRGregory Fontana, MD
Los Robles Regional Medical Center
PRINCIPAL_INVESTIGATORGuilherme Attizzani, MD
UH, Cleveland Medical Center
PRINCIPAL_INVESTIGATORBasel Ramlawi
Lankenau Heart Institute
Outcome results
None listed