CoreValve Evolut Pro Prospective Registry

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medstar Health Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Symptomatic severe aortic stenosis

Intermediate, high or extreme surgical risk

The institutional Heart Team determines that transcatheter aortic valve replacement with an Evolut Pro device is appropriate

Treatment Details

Interventions

• CoreValve Evolut PRO (Transcatheter Aortic Valve Replacement (TAVR))

Participant Groups

Group I: Non-CT Cohort Experimental Treatment 1 Intervention

1. Compare the rate of ≥mild PVL with the Evolut PRO with a propensity score matched cohort of historical control subjects who underwent TAVR with the Evolut R and/or CoreValve within the MedStar Health System. 2. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict ≥mild PVL. 3. Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict PPM implantation.

Group II: CT Cohort Experimental Treatment 1 Intervention

1. Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification. 2. Comparison of the rate of PPM implantation in patients with none/mild versus moderate/severe LVOT calcification. 3. Determine how the Evolut PRO conforms to LVOT calcification. 4. Compare the impact of LVOT calcification on the implantation depth of the Evolut PRO. 5. Analyze the interaction and geometry of the Evolut PRO in patients with moderate/severe LVOT calcification. 6. Assess for leaflet thickening, subclinical leaflet thrombosis and/or restricted leaflet motion 30-60 days after TAVR.

Who Is Running the Clinical Trial?

Medstar Health Research Institute

Lead Sponsor

Trials

202

Recruited

187,000+

Neil J. Weissman

Medstar Health Research Institute

Chief Executive Officer since 2018

Medical degree from Cornell University Medical College

Stephen R.T. Evans

Medstar Health Research Institute

Chief Medical Officer since 2018

MD

Medtronic Cardiovascular

Industry Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University