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

NCT ID: NCT07058935

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-17

Study Completion Date

2035-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Valve Disease, Heart

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Mitral Valve-in-Valve

Patients who have undergone or will undergo a transcatheter mitral valve-in-valve procedure.

No interventions assigned to this group

Mitral Valve-in-Ring

Patients who have undergone or will undergo a transcatheter mitral valve-in-ring procedure.

No interventions assigned to this group

Tricuspid Valve-in-Valve

Patients who have undergone or will undergo a transcatheter tricuspid valve-in-valve procedure.

No interventions assigned to this group

Tricuspid Valve-in-Ring

Patients who have undergone or will undergo a transcatheter tricuspid valve-in-ring procedure.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role collaborator

National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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John Hunter Hospital

New Lambton Heights, , Australia

Site Status NOT_YET_RECRUITING

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status NOT_YET_RECRUITING

MGM Healthcare Pvt Ltd

Chennai, Tamil Nadu, India

Site Status NOT_YET_RECRUITING

The Madras Medical Mission

Chennai, Tamil Nadu, India

Site Status NOT_YET_RECRUITING

Waikato Hospital

Hamilton, , New Zealand

Site Status NOT_YET_RECRUITING

National Heart Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Ramathibodi Hospital

Bangkok, , Thailand

Site Status NOT_YET_RECRUITING

Countries

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Australia Hong Kong India New Zealand Singapore Thailand

Central Contacts

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Deborah Yip

Role: CONTACT

+65-67042301

Facility Contacts

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Clinical Research Coordinator

Role: primary

02 4985 5433

Clinical Research Coordinator

Role: primary

+852-35052211

Clinical Research Coordinator

Role: primary

+852-35061088

Clinical Research Coordinator

Role: primary

9677178012

Clinical Research Coordinator

Role: primary

9940484306

Clinical Research Coordinator

Role: primary

+64 7 839 7136

Clinical Research Coordinator

Role: primary

+65-7042274

Clinical Research Coordinator

Role: primary

+66819068607

Other Identifiers

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2024-4264

Identifier Type: -

Identifier Source: org_study_id

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