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

Recruiting

• Conditions: Aortic Valve Replacement
• Interventions: Device: SAVR; Device: TAVR

• Registration Number: NCT03002272
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

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.

Detailed Description

There is limited available information on long term TAVR valve function. 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. Up-to-date echocardiography will be performed and analyzed in a Core Lab to assess valve function yearly.

Study Timeline

• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-23
• Study Start: 2018-02-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26
• Primary Completion: 2024-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prosthetic valve dysfunction	7 years	Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation

Secondary Outcome Measures

Name	Time	Method
Increase in severity of aortic regurgitation	upto 7 years	Increase in severity of aortic regurgitation by one or more grading of severity
Change in functional status	discharge from hospital	Change in functional status from baseline and discharge per NYHA classification

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States