An observational study in Structural Heart Disease and Mitral Valve Regurgitation, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Observational
A significant number of patients with severe mitral and tricuspid valve disease have been previously treated with either valve repair with annuloplasty rings or valve replacement with bioprosthetic/mechanical valves. Over time, these bioprosthetic valves and rings may fail resulting in recurrence of the valvular disease. The technical aspects of a re-do operation are complex and these patients are often times at high risk for repeat open surgery. The emergence of transcatheter options may provide a safer and less invasive alternative to open surgery. Majority of the data currently exist for Western cohorts with limited longer-term outcomes. Data on this therapy is particularly lacking in the Asia-Pacific region, especially important in the light of known differences in body habitus and size.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 15 is below the median of 157 across 168 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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This is 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 from 1 Jan 2023 to 31 Dec 2035.
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Exclusion Criteria:
Patient planned to undergo a Mitral valve-in-valve/valve-in-ring procedure.
Patient that had at least one documented Mitral valve-in-valve/valve-in-ring procedure done during the period of 1 Jan 2023 to current date.
All-cause mortality
Rate of All-cause mortality in enrolled patients
Time frame: 10 years
Procedural technical success rate
Rate of Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure)
Time frame: Immediately after operation
Procedural complication rate
Rate of Procedural technical success (defined per Mitral Valve Academic Research Consortium (MVARC) criteria at exit from the hybrid suite as patient alive with successful access, delivery, and retrieval of the device delivery system, successful deployment and correct position of the first intended device, and freedom from emergency surgery or reintervention associated with the device or access procedure)
Time frame: Periprocedural
Major adverse cardiovascular events rate
Rate of Major adverse cardiovascular events in enrolled patients
Time frame: 10 years
New York Heart Association (NYHA) classification
NYHA class of enrolled patients
Time frame: 10 years
Echocardiographic result
Rate of Major adverse cardiovascular events in enrolled patients
Time frame: 10 years
Plan to share: No
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Prince of Wales Hospital, Shatin, Hong Kong