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Understanding the Performance of the Dafodil Neo Prosthetic Heart Valve: Mid-term Results in patients with the implant

Mid-term Clinical outcomes of Dafodil Neo Pericardial Bioprosthesis- Single center, Single-arm, Ambispective, Observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094976
Enrollment
150
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: I352- Nonrheumatic aortic (valve) stenosis with insufficiency Health Condition 2: I341- Nonrheumatic mitral (valve) prolapse Health Condition 3: I080- Rheumatic disorders of both mitraland aortic valves

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Fortis Escorts Heart Institute & Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subject successfully implanted with Dafodil Neo Pericardial Bioprosthesis (mitral/aortic or double valve replacements) Patient or his/her Legally Acceptable Representative (LAR) should provide informed consent for study participation as per applicable local requirements. Patient willing to undergo all study procedures and adhere to data collection and follow-up requirements

Exclusion criteria

Exclusion criteria: Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study Patients with any non-cardiac condition that is expected to limit their life expectancy to less than 5 years. Patients in concomitant end stage renal disease requiring dialysis at screening.

Design outcomes

Primary

MeasureTime frame
Improvement in hemodynamic performance (EOA, Mean gradient, Major paravalvular leak) when compared to baseline. Hemodynamic Improvement EOA, EOAI Peak and Mean Pressure Gradients, Valvular Regurgitation, Paravalvular Leak Prosthesis-Patient Mismatch, Cardiac Output, Cardiac Index Calcification of Valve Leaflets NYHA Functional Class Class I Class II Class III Class IV All-cause Mortality Re-hospitalization Timepoint: 30 days—

Secondary

MeasureTime frame
Hemodynamic Improvement Effective Office Area (EOA), Effective Orifice Area Index (EOAI) Peak and Mean Pressure Gradients, Valvular Regurgitation, Paravalvular Leak Prosthesis-Patient Mismatch, Cardiac Output, Cardiac Index Calcification of Valve Leaflets NYHA Functional Class Class I: No symptoms, no activity limitation Class II: Mild symptoms, slight activity limitation Class III: Marked limitation, symptoms at less-than-ordinary activity Class IV: Severe limitation, symptoms at rest, bedbound patients All-cause Mortality Re-hospitalization Timepoint: Baseline Discharge 30 days 6 month 1 year 2 years 3 years—

Countries

India

Contacts

Public ContactRitwick Raj Bhuyan

Fortis Escorts Heart Institute & Research Centre

neocare2908@gmail.com9870217444

Outcome results

None listed

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