NCT03002272

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Replacement

Interventions

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

Timeline

• Start date: 2018-02-20
• Primary completion: 2024-01-01
• Completion: 2028-01-01
• First posted: 2016-12-23
• Last updated: 2023-05-26

Locations

1 site across 1 country: United States