Floret ASD Registry(Floret ASD Occluder is a self-expandable, double-disc device made from a Nitinol wire mesh)

Not yet recruiting

Conditions: Other heart disorders in diseasesclassified elsewhere,

Registration Number: CTRI/2025/05/086644

Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary: Study Name: A retrospective, single-arm, multicenter, observational, registry study toevaluate the safety and performance of Floret™ Atrial Septal DefectOccluder in a real-world setting.

Short Title: Floret ASD Registry

Protocol ID,Version& Date:MLS/Floret ASD Registry -1\_version 1.0.0\_09-Jan-2025

Study Device: Floret™ Atrial Septal Defect Occluder

Indication: The Floret™ ASD Occluder is a percutaneous, transcatheter closure devicefor occlusion of the atrial septal defect in the secundum position or patientswho have undergone a fenestrated Fontan procedure, and who now have toclose the fenestration.Patients indicated for ASD closure have echocardiographic evidence ofostium secundum atrial septal defect or clinical evidence of RV volumeoverload. (i.e. 1.5:1 degree of left to right shunt or RV enlargement).

Objective: To evaluate the safety and performance of Floret™ Atrial Septal DefectOccluder.

Study Design: A retrospective, single-arm, multicenter, observational, registry study

Rationale of the studyThe Floret™ ASD Occluder is designed for the minimally invasive closure of atrial septaldefects (ASD) in the secundum position and for closing fenestrations in patients post-Fontanprocedure. While its clinical utility has been established, real-world data on its safety andperformance remain limited. This study aims to evaluate the device’s safety and effectiveness ina diverse, real-world population, addressing an important knowledge gap and providing insightsinto its performance in routine clinical practice.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 263

Inclusion Criteria

Patients who have been treated with Floret(TM) Atrial Septal Defect Occluder.

Exclusion Criteria

Patients who have not been treated with Floret(TM) Atrial Septal Defect Occluder.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Successful closure	1.Time Frame: Intra-operative \| 2.Time Frame: Intra-operative, \| through 1 month, 3 months, 6 months, 1 year \| 3.Time Frame: Post-operative
2.Technical implant success	1.Time Frame: Intra-operative \| 2.Time Frame: Intra-operative, \| through 1 month, 3 months, 6 months, 1 year \| 3.Time Frame: Post-operative
3.Post-procedural complications	1.Time Frame: Intra-operative \| 2.Time Frame: Intra-operative, \| through 1 month, 3 months, 6 months, 1 year \| 3.Time Frame: Post-operative

Secondary Outcome Measures

Name	Time	Method
1.Occluder displacement	2.Atrial fibrillation

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