The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry

Prince of Wales Hospital, Shatin, Hong Kong15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Structural Heart Disease Mitral Valve Regurgitation

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 21 2. 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) Exclusion Criteria: 1. Active endocarditis 2. Any other conditions which investigator deems unsuitable for participation.

Outcomes

Primary Outcomes

All-cause mortality

Rate of All-cause mortality in enrolled patients

Time frame: 10 years

Secondary Outcomes

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

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

The Asia-Pacific Mitral & Tricuspid Valve-in-Valve/Valve-in-Ring Registry

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts