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

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