Aortic Stenosis
Conditions
Brief summary
The primary objective of this study is to evaluate the real-world performance of the CoreValve Evolut PRO transcatheter aortic valve, including leaflet function, in a prospective observational registry.
Detailed description
The CoreValve Evolut PRO transcatheter aortic valve was approved by the FDA in March 2017 to treat patients with symptomatic severe aortic stenosis at high or extreme risk for open heart surgery, and in July 2017 for intermediate risk patients. This latest generation device features an outer wrap to improve annular sealing and reduce paravalvular leak. In this observational study, baseline demographic and imaging characteristics, procedural details and clinical outcomes of patients undergoing transcatheter aortic valve replacement with the CoreValve Evolut PRO will be prospectively collected into a registry database. The institutional Heart Team will select patients according to standard practice.
Interventions
DEVICETAVR
Transcatheter Aortic Valve Replacement
Sponsors
Medtronic Cardiovascular
Medstar Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Inclusion criteria
1. Symptomatic severe aortic stenosis 2. Intermediate, high or extreme surgical risk 3. The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate
Exclusion criteria
1. Subject unable or unwilling to give informed consent 2. For subjects in the CT arm only, renal function precluding the administration of iodinated contrast for cardiac CT (eGFR \< 30 ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media. 3. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Valve - related Dysfunction | 30 Days | Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR |
| All Cause Mortality | 30 days | all causes of death |
| All Stroke (disabling and non-disabling | 30 days | Stroke will evaluated using the VARC-2 definition |
| Life Threatening Bleeding | 30 Days | Life Threatening Bleeding will be evaluated using the VARC-2 definition |
| Acute Kidney Injury Stage 2 or 3 | 30 days | AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI |
| Coronary Artery Obstruction requiring intervention | 30 days | This will be assessed if by noting whether the patient has a re intervention |
| Major Vascular Complication | 30 days | Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication |
| Device success: | 30 days | Absence of procedural mortality Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient\<20 mm Hg or peak velocity\<3 m/s, AND no moderate or severe prosthetic valve regurgitation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prosthetic valve dysfunction #2 | 1 year | Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab |
| Prosthetic valve dysfunction #3 | 1 year | Abnormal leaflet thickening on CT as determined by the CT Core lab |
| Prosthetic valve dysfunction #4 | 1 year | Decreased leaflet mobility on CT as determined by the CT Core lab |
| Prosthetic valve dysfunction | 1 year | Leaflet thrombosis on CT as determined by the CT Core lab |
| Reduction in PVL | Discharge thru to 1 year | This will be evaluated by echo core lab findings |
| Prosthetic valve dysfunction #1 | 1 year | Mean aortic valve gradient ≥20 mm Hg |
Countries
United States
Outcome results
None listed