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| Name | Class |
|---|---|
| Medtronic Cardiovascular | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT Cohort |
|
| |
| Non-CT Cohort |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR | Device | Transcatheter Aortic Valve Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device success: | 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) | 30 days |
| All Cause Mortality | all causes of death | 30 days |
| All Stroke (disabling and non-disabling | Stroke will evaluated using the VARC-2 definition | 30 days |
| Life Threatening Bleeding | Life Threatening Bleeding will be evaluated using the VARC-2 definition | 30 Days |
| Acute Kidney Injury Stage 2 or 3 | AKI will be evaluated using the VARC-2 definition of Stage 2 or 3 AKI | 30 days |
| Coronary Artery Obstruction requiring intervention | This will be assessed if by noting whether the patient has a re intervention | 30 days |
| Major Vascular Complication | Major Vascular Complication will be evaluated using the VARC-2 definition of Major Vascular Complication | 30 days |
| Valve - related Dysfunction |
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic valve dysfunction #1 | Mean aortic valve gradient ≥20 mm Hg | 1 year |
| Prosthetic valve dysfunction #2 | Moderate-severe transvalvular aortic regurgitation as determined by the echo core lab |
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Inclusion Criteria:
Exclusion Criteria:
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This study is a prospective registry of subjects with symptomatic severe aortic stenosis undergoing TAVR with a commercially-approved self-expanding transcatheter heart valve. A subgroup of subjects will undergo additional research contrast-enhanced 4D CT at 30-60 days after TAVR. Otherwise, all additional test and TAVR implantation procedures are as per standard of care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Medstar Union Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38769727 | Derived | Merdler I, Case BC, Bhogal S, Reddy PK, Zhang C, Ali S, Gallino PE, Jackman C, Ben-Dor I, Satler LF, Cohen JE, Rogers T, Waksman R. Temporal trends with the Evolut family of self-expanding transcatheter heart valves: A single-center experience. Catheter Cardiovasc Interv. 2024 Jul;104(1):125-133. doi: 10.1002/ccd.31088. Epub 2024 May 20. | |
| 35321859 |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR
| 30 Days |
| 1 year |
| Prosthetic valve dysfunction #3 | Abnormal leaflet thickening on CT as determined by the CT Core lab | 1 year |
| Prosthetic valve dysfunction #4 | Decreased leaflet mobility on CT as determined by the CT Core lab | 1 year |
| Prosthetic valve dysfunction | Leaflet thrombosis on CT as determined by the CT Core lab | 1 year |
| Reduction in PVL | This will be evaluated by echo core lab findings | Discharge thru to 1 year |
| Baltimore |
| Maryland |
| 21218 |
| United States |
| Medranda GA, Soria Jimenez CE, Torguson R, Case BC, Forrestal BJ, Ali SW, Shea C, Zhang C, Wang JC, Gordon P, Ehsan A, Wilson SR, Levitt R, Parikh P, Bilfinger T, Hanna N, Buchbinder M, Asch FM, Weissman G, Shults CC, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R, Rogers T. Lifetime management of patients with symptomatic severe aortic stenosis: a computed tomography simulation study. EuroIntervention. 2022 Aug 5;18(5):e407-e416. doi: 10.4244/EIJ-D-21-01091. |
| 33272031 | Derived | Forrestal BJ, Case BC, Yerasi C, Shea C, Torguson R, Zhang C, Ben-Dor I, Deksissa T, Ali S, Satler LF, Shults C, Weissman G, Wang JC, Khan JM, Waksman R, Rogers T. Risk of Coronary Obstruction and Feasibility of Coronary Access After Repeat Transcatheter Aortic Valve Replacement With the Self-Expanding Evolut Valve: A Computed Tomography Simulation Study. Circ Cardiovasc Interv. 2020 Dec;13(12):e009496. doi: 10.1161/CIRCINTERVENTIONS.120.009496. Epub 2020 Dec 4. |
| D014694 |
| Ventricular Outflow Obstruction |