CoreValve Evolut Pro Prospective Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis
• Intervention / Treatment: Device: TAVR

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • MedStar Union Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CT Cohort; Compare the rate of ≥mild PVL in patients with none/mild versus moderate/severe LVOT calcification.; Comparison of the rate of PPM implantation in patients with none/mild versus moderate/severe LVOT calcification.; Determine how the Evolut PRO conforms to LVOT calcification.; Compare the impact of LVOT calcification on the implantation depth of the Evolut PRO.; Analyze the interaction and geometry of the Evolut PRO in patients with moderate/severe LVOT calcification.; Assess for leaflet thickening, subclinical leaflet thrombosis and/or restricted leaflet motion 30-60 days after TAVR.	Device: TAVR; Transcatheter Aortic Valve Replacement
Non-CT Cohort; 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.; Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict ≥mild PVL.; Determine which features of LVOT calcification (volume, location relative to aortic annulus and sinuses, prominence into the LVOT lumen) predict PPM implantation.	Device: TAVR; Transcatheter Aortic Valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Valve related dysfunction will be evaluated by determining whether the subject has a repeat procedure such as a BAV, TAVI, or SAVR	30 Days

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Collaborators: Medtronic Cardiovascular

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: EPROMPT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No