The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry (AP ViV Registry)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorNational Heart Centre Singapore

About this trial

A retrospective and prospective, observational, multicenter cohort study of consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in Asia-Pacific.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 21

Had at least one documented Mitral valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Mitral valve-in-valve/valve-in-ring procedure. (Prospective) OR Had at least one documented Tricuspid valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date. (Retrospective) OR Planned to undergo a Tricuspid valve-in-valve/valve-in-ring procedure. (Prospective)

Disqualifiers

Active endocarditis

Any other conditions which investigator deems unsuitable for participation.

Trial population

Consecutive patients undergoing transcatheter mitral/tricuspid ViV or ViR procedure with balloon expandable valve across participating sites in Asia-Pacific from 1 Jan 2023 to 31 Dec 2035.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 4 trial groups
Group A: Mitral Valve-in-Valve
Group B: Mitral Valve-in-Ring
Group C: Tricuspid Valve-in-Valve
Group D: Tricuspid Valve-in-Ring

Trial outcomes

Primary outcomes

1

All-cause mortality

Time frame
From date of procedure to 10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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

National Heart Centre Singapore

Lead sponsor

Edwards Lifesciences

Collaborator