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Study of using patients own tissues to construct mitral valve compared to mechanical valve replacement

Autopericardial Mitral valve re-implantation versus Mitral valve replacement with prosthetic valve: A comparative study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/032759
Enrollment
100
Registered
2021-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: I052- Rheumatic mitral stenosis with insufficiency

Interventions

Intervention1: MV Auto: Autopericardial Mitral valve reconstruction Control Intervention1: MVR: Mitral valve replacement

Sponsors

Sri Jayadeva institute of Cardiovascular Sciences and research
Lead Sponsor
Rakesh Naik L Prabhu Manohar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with mitral valve diseases including stenosis, regurgitation, prolapse and infective endocarditis, not amenable for mitral repair.

Exclusion criteria

Exclusion criteria: Severe LV dysfunction, multiorgan failure

Design outcomes

Primary

MeasureTime frame
Survival Disease free survival Symptom free survival Freedom from re-intervention Timepoint: At discharge , 4 weeks 6 months 1 year 5 years

Secondary

MeasureTime frame
Post-operative Mitral Valve Orifice Area (MVOA) Post-operative mitral valve residual gradient Left ventricular regression post surgery Timepoint: 1 month 3 moth 6 months 1 year 5 years

Countries

India

Contacts

Public ContactPrabhu Manohar

Sri Jayadeva Institute of Cardiovascular Sciences and Research

dr.prabhu.manohar.03@gmail.com9483964910

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026