Observational Real World National Registry of Dafodil.

A Prospective, Post-market, Multi-center, Single-arm, Real-world Observational Registry to evaluate safety and performance of Dafodil™ Pericardial Bioprosthesis in patients who underwent replacement of their natural or prosthetic aortic or mitral valve. - DAWN (Dafodil pericArdial bioprosthesis real-World National registry

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/07/044021

Enrollment

300

Registered

2022-07-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis Health Condition 2: I342- Nonrheumatic mitral (valve) stenosis

Interventions

Intervention1: Dafodil™ Pericardial Bioprosthesis: Dafodil™ Pericardial Bioprosthesis is indicated for use in patients whose valvular disease is sufficiently advanced to warrant replacement of their n

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Patients implanted with Dafodil™ Pericardial Bioprosthesis or with its subsequent advanced versions. 2. Patients or LAR (Legally Acceptable Representative) has given written informed consent for participation prior to enrolment. 3. Patient is willing to undergo all study procedures and follow-up requirements.

Exclusion criteria

Exclusion criteria: NIL

Design outcomes

Primary

Measure	Time frame
Late Valve-related adverse events compared with OPC. The following valve-related adverse events will be evaluated: oThromboembolism oValve Thrombosis o Major Haemorrhage o Major Paravalvular leak o Endocarditis Timepoint: greater than 30 days to 3 year	—

Secondary

Measure	Time frame
ThromboembolismTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Valve thrombosisTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Bleeding/HaemorrhageTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Paravalvular leakTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;EndocarditisTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Valve-Related Adverse Event Major adverse valve-related events include the following: (1) valve-related mortality, (2) all valve-related morbidity, and (3) need for new permanent pacemaker or defibrillator within 14 days after the valve intervention. Timepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Early MortalityTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Valve related mortalityTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;HemolysisTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Structural valve deteriorationTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Non-structural dysfunctionTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;ReinterventionTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;ExplantTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Improvement in NYHA classTimepoint: Time frame: Pre-procedure, Discharge, 30 days, 6 months, 1 year and annually thereafter till 5 years;Improvement in Echocardiographic parametersTimepoint: Time frame: Pre-procedure, 30 days, 6 months, 1 year and annually thereafter till 5 years	—

Measure

Time frame

ThromboembolismTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Valve thrombosisTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Bleeding/HaemorrhageTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Paravalvular leakTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;EndocarditisTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Valve-Related Adverse Event Major adverse valve-related events include the following: (1) valve-related mortality, (2) all valve-related morbidity, and (3) need for new permanent pacemaker or defibrillator within 14 days after the valve intervention. Timepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Early MortalityTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Valve related mortalityTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;HemolysisTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Structural valve deteriorationTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Non-structural dysfunctionTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;ReinterventionTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;ExplantTimepoint: Time frame: 30 days, 6 months, 1 year and annually thereafter till 5 years;Improvement in NYHA classTimepoint: Time frame: Pre-procedure, Discharge, 30 days, 6 months, 1 year and annually thereafter till 5 years;Improvement in Echocardiographic parametersTimepoint: Time frame: Pre-procedure, 30 days, 6 months, 1 year and annually thereafter till 5 years

—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Science Pvt. Ltd.

Ashok.thakkar@merillife.com9879443584

Outcome results

None listed

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