Clinical trial NCT03423459: CoreValve Evolut Pro Prospective Registry
Official title: CoreValve Evolut Pro Prospective Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Medtronic Cardiovascular
First posted: 2018-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Device success:
timeFrame: 30 days
measure: All Cause Mortality
timeFrame: 30 days
measure: All Stroke (disabling and non-disabling
timeFrame: 30 days
measure: Life Threatening Bleeding
timeFrame: 30 Days
measure: Acute Kidney Injury Stage 2 or 3
timeFrame: 30 days
measure: Coronary Artery Obstruction requiring intervention
timeFrame: 30 days
measure: Major Vascular Complication
timeFrame: 30 days
measure: Valve - related Dysfunction
timeFrame: 30 Days
Secondary outcomes:
measure: Prosthetic valve dysfunction #1
timeFrame: 1 year
measure: Prosthetic valve dysfunction #2
timeFrame: 1 year
measure: Prosthetic valve dysfunction #3
timeFrame: 1 year
measure: Prosthetic valve dysfunction #4
timeFrame: 1 year
measure: Prosthetic valve dysfunction
timeFrame: 1 year
measure: Reduction in PVL
timeFrame: Discharge thru to 1 year
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
Study officials:
References:
citation: 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.
citation: 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.