Health TrialsbyHealthPanel

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

ConditionAortic Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedstar Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial population

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

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TAVR1 intervention
Group B: SAVR1 intervention

Trial outcomes

Primary outcomes

1

Prosthetic valve dysfunction

Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation

Time frame
7 years

Secondary outcomes

1

Change in functional status

Change in functional status from baseline and discharge per NYHA classification

Time frame
discharge from hospital
2

Increase in severity of aortic regurgitation

Increase in severity of aortic regurgitation by one or more grading of severity

Time frame
upto 7 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

Source ClinicalTrials.gov
Apply now