Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TAVR, SAVR.
- Who it may be relevant to
- Registry conditions: Aortic Valve Replacement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Prosthetic valve dysfunction [Time frame: 7 years]
Secondary outcome measures (2)
- Change in functional status [Time frame: discharge from hospital]
- Increase in severity of aortic regurgitation [Time frame: upto 7 years]
Eligibility criteria
Inclusion criteria for TAVR subjects
a) TAVR performed more than 3 years ago
Exclusion criteria
- Subjects unable to consent to participate, unless the subject has a legally authorized representative
- Subjects unwilling to participate
- Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)
- Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)
Inclusion criteria for SAVR subjects
- SAVR performed more than 3 years ago
- Propensity matched to an enrolled TAVR subject
Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless the subject has a legally authorized representative f) Subjects unwilling to participate g) Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Washington Hospital Center — Washington D.C.
Identifiers
NCT: NCT03002272 · TAVR Durability