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Floret PDA Registry(Floret Patent Ductus Arteriosus Occluder-self-expandable. Mushroom shaped implant device made from a Nitinol wire mesh)

A retrospective, single-arm, multi-center, observational, registry study to evaluate the safety and performance of Floret(TM) Patent Ductus Arteriosus Occluder. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/086969
Enrollment
245
Registered
2025-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Meril Life Sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who underwent percutaneous, transcatheter PDA closure using the Floret(TM) PDA Occluder

Exclusion criteria

Exclusion criteria: Patients who has not been treated with Floret(TM) PDA Occluder

Design outcomes

Primary

MeasureTime frame
1.Successful PDA Closure 2.Incidence of adverse events and major complications Timepoint: 1. Time frame: Post procedure 2. Time frame: Upto discharge—

Secondary

MeasureTime frame
1. Procedure time 2. Length of Hospital Stay 3.Ease of use 4.Incidence of adverse events and major complicationsTimepoint: 1. Time Frame: Intra-operative 2. Time Frame: Admission to discharge 3.Time Frame: Intra-operative 4.Time frame: 1-month, 3-month, 6-month and 12-month follow-up—

Countries

India

Contacts

Public ContactDr Kirankumar Shetty

Meril Life Sciences Pvt. Ltd

kirankumar.shetty@merillife.com9743700109

Outcome results

None listed

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