WHO ICTRP trial

Observational Real World National Registry of Dafodil.

CTRI/2022/07/044021 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2022/07/044021
Public title Observational Real World National Registry of Dafodil.
Scientific title 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…
Primary sponsor Meril Life Sciences Pvt Ltd
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type PMS
Phase Post Marketing Surveillance
Countries India
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 natural valve with a prosthetic one. It…
Registration date Jul 14, 2022
Target size 300
Secondary IDs NIL
Registry page ctri.nic.in

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