NCT03423459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 6, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

January 18, 2018

Last Update Submit

May 25, 2023

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (6)

  • Prosthetic valve dysfunction #1

    1 year

  • Prosthetic valve dysfunction #2

    1 year

  • Prosthetic valve dysfunction #3

    1 year

  • Prosthetic valve dysfunction #4

    1 year

  • Prosthetic valve dysfunction

    1 year

  • +1 more secondary outcomes

Study Arms (2)

CT Cohort

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.

Device: TAVR

Non-CT Cohort

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.

Device: TAVR

Interventions

TAVRDEVICE

Transcatheter Aortic Valve Replacement

CT CohortNon-CT Cohort

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Subject unable or unwilling to give informed consent
  • Pregnancy or intent to become pregnant prior to completion of all protocol follow-up procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Related Publications (3)

  • 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.

    PMID: 38769727DERIVED

  • 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.

    PMID: 35321859DERIVED

  • 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.

    PMID: 33272031DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 6, 2018

Study Start

January 18, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)