| CTRI Number |
CTRI/2025/05/086644 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Floret ASD Registry(Floret ASD Occluder is a self-expandable, double-disc device made from a Nitinol wire mesh) |
|
Scientific Title of Study
|
A retrospective, single-arm, multicenter, observational, registry study to evaluate the safety and performance of Floret(TM) Atrial Septal Defect Occluder in a real-world setting. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLS/Floret ASD Registry - 1, V1.0.0 dated 09-Jan-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt. Ltd, Buiding number 6, 3rd floor, Near Bilakhia Stadium,Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Life Science Pvt. Ltd,
Survey No. 135, 139, Bilakhia House,
Muktanand Marg, Chala, Vapi,
Valsad, Gujarat, 396191, India |
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala, Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Patel |
Geetanjali Medical College and Hospital |
1st Floor, Interventional Cardiology,Hiranmagri Extension, Manwakhera NH-8 Bypass, Near Eklingpura, Chouraha, Udaipur, Rajasthan 313001
Udaipur
RAJASTHAN |
9530079043
drrameshpatel1982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee Geetanjali Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients who have been treated with Floret(TM) Atrial Septal Defect Occluder |
|
| ExclusionCriteria |
| Details |
Patients who have not been treated with Floret(TM) Atrial Septal Defect Occluder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Successful closure
2.Technical implant success
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
|
| Outcome |
TimePoints |
1.Occluder displacement
2.Atrial fibrillation
3.Serious adverse events/Adverse events
4.Ease of use |
1.Time Frame: Post-operative
2.Time Frame: Intra-operative
3.Time Frame: Postoperative, through 1 month, 3 months, 6 months, 1 year
4.Time Frame: Intra-operative |
|
|
Target Sample Size
|
Total Sample Size="263"
Sample Size from India="263"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Name: A retrospective, single-arm, multicenter, observational, registry study to
evaluate the safety and performance of Floret™ Atrial Septal Defect
Occluder 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 device
for occlusion of the atrial septal defect in the secundum position or patients
who have undergone a fenestrated Fontan procedure, and who now have to
close the fenestration.
Patients indicated for ASD closure have echocardiographic evidence of
ostium secundum atrial septal defect or clinical evidence of RV volume
overload. (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 Defect
Occluder.
Study Design: A retrospective, single-arm, multicenter, observational, registry study
Rationale of the study
The Floret™ ASD Occluder is designed for the minimally invasive closure of atrial septal
defects (ASD) in the secundum position and for closing fenestrations in patients post-Fontan
procedure. While its clinical utility has been established, real-world data on its safety and
performance remain limited. This study aims to evaluate the device’s safety and effectiveness in
a diverse, real-world population, addressing an important knowledge gap and providing insights
into its performance in routine clinical practice.
|