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Strategies to Prevent Transcatheter Heart Valve Dysfunction in Low Risk Transcatheter Aortic Valve Replacement

NCT03557242 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-01-04

No results posted yet for this study

Summary

100 subjects in the each of the treatment arms of the study (total 200 treatment arm subjects) and up to 100 subjects in the registry arm of the study.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

TAVR

Transcatheter Aortic Valve Replacement

OTHER

Warfarin plus Aspirin

Subjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR

OTHER

Aspirin Only

Subjects randomized to this arm will receive aspirin only post TAVR

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Ron S Waksman, MD · MedStar Cardiovascular Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2023-07-30
Completion
2023-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557242 on ClinicalTrials.gov