Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Medstar Health Research Institute
Study ID
NCT03002272
Status
Recruiting
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Conditions

  • Aortic Valve Replacement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TAVR — DEVICE
    subjects that underwent TAVR more than 3 years ago
  • SAVR — DEVICE
    Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Study Details

In this observational study, the investigators will enroll subjects who underwent TAVR or SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be collected, alongside clinical and echocardiographic data from subsequent follow-up visits.

Key Dates

First listed
Dec 23, 2016
Start date
Feb 20, 2018
Status verified
May 2023
Primary completion
Jan 31, 2024
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: TAVR
    This observational study will enroll subjects that underwent TAVR more than 3 years ago.
  • Arm: SAVR
    Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago

Primary Outcome Measure

Prosthetic valve dysfunction [ Time Frame: 7 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington Hospital CenterWashington D.C.District of Columbia20010
Megan Rowland
[email protected]
202-877-2959
Ron Waksman, MD (PRINCIPAL_INVESTIGATOR)

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Washington Hospital Center· Washington D.C., DC