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

Not yet recruiting

Conditions: Other heart disorders in diseasesclassified elsewhere,

Registration Number: CTRI/2025/05/086969

Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary: Study Title: A retrospective, single-arm, multi-center, observational,registry study to evaluate the safety and performance ofFloret™ Patent Ductus Arteriosus Occluder.

Indication: The Floret™ PDA Occluder is percutaneous, transcatheterdevice especially designed for closure of normally locatedpatent ductus arteriosus independent of shape or size.Treatment is feasible in the very young pediatric population.

Short Title: Floret PDA Occluder

Protocol ID, Version & Date: MLS/Floret PDA Registry -1\_Version\_1.0.0\_16-Jan-2025

Objective: The aim of this study is to evaluate the safety andperformance of Floret™ Patent Ductus Arteriosus Occluderin real-world settings.

Study Design: A retrospective, single-arm, multi-center, observational,registry study.

Rationale: PDA is a common congenital heart condition, particularly in preterm infants, and itssuccessful closure is critical to reducing associated risks such as chronic respiratorydiseases, pulmonary hemorrhage, and mortality. While various methods, including surgicaland transcatheter closure, have been used to treat PDA, there remains a need for a reliableand minimally invasive option suitable for a broad range of patients, including those in thevery young pediatric population. The Floret™ Patent Ductus Arteriosus Occluder, apercutaneous, transcatheter device designed for closure of PDAs regardless of shape or size,offers a promising solution. This study aims to evaluate the safety and performance of theFloret™ PDA Occluder, providing valuable clinical data to support its use as an effectivetreatment option for PDA closure.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 245

Inclusion Criteria

Patients who underwent percutaneous, transcatheter PDA closure using the Floret(TM) PDA Occluder.

Exclusion Criteria

Patients who has not been treated with Floret(TM) PDA Occluder.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Successful PDA Closure	1. Time frame: Post procedure \| 2. Time frame: Upto discharge
2.Incidence of adverse events and major complications	1. Time frame: Post procedure \| 2. Time frame: Upto discharge

Secondary Outcome Measures

Name	Time	Method
1. Procedure time	2. Length of Hospital Stay

Trial Locations

Locations (1): Geetanjali Medical College and Hospital
🇮🇳
Udaipur, RAJASTHAN, India
Geetanjali Medical College and Hospital
🇮🇳Udaipur, RAJASTHAN, India
Dr Ramesh Patel
Principal investigator
9530079043
drrameshpatel1982@gmail.com