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Checking the safety of balloon dilatation in explanted mechanical heart valves

Safety and Feasibility of balloon dilatation across the mechanical heart valves – An In-vitro study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058611
Enrollment
20
Registered
2023-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: I088- Other rheumatic multiple valve diseases

Interventions

Intervention1: NIl: Nil Control Intervention1: Nil: Nil

Sponsors

The Madras Medical Mission Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patients who will undergo repeat cardiac valve replacement for a left-sided obstructive mechanical valve due to thrombus or pannus, infective endocarditis, or paravalvular leak, as recommended by the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery will be included in this study. The explanted failed old mechanical valve will be tested in a bench model after obtaining written informed consent from the patient.

Exclusion criteria

Exclusion criteria: 1 Ball and cage mechanical valve 2 Bioprosthetic valve 3 Not willing to give written informed consent 4 Right-sided valves from tricuspid and pulmonary positions 5 Serology-positive patients for HBsAg, Hepatitis C virus, or Human immunodeficiency virus.

Design outcomes

Primary

MeasureTime frame
To assess the structural changes of the mechanical heart valves namely annular fracture, leaflet fracture, leaflet dislodgement from the hinges, & leaflet deformation during 1:1 sized balloon dilatation at the rated burst pressure (RBP) in the central & lateral orifices or the minor & major orifices of the explanted mechanical valves.Timepoint: At the time of balloon dilatation

Secondary

MeasureTime frame
To assess the balloon size required for leaflet fracture or leaflet dislodgement from the hinges of the explanted mechanical valves. To describe the various pathological changes in the failed mechanical valves. To describe the clinical presentation & echocardiographic findings of the stuck valve patients. Timepoint: At the time of balloon dilatation

Countries

India

Contacts

Public ContactNandhakumar V

The Madras Medical Mission

nandha.intervention@gmail.com9715278871

Outcome results

None listed

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