| CTRI Number |
CTRI/2025/05/086969 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Floret PDA Registry(Floret Patent Ductus Arteriosus Occluder-self-expandable. Mushroom shaped implant device made
from a Nitinol wire mesh) |
|
Scientific Title of Study
|
A retrospective, single-arm, multi-center, observational, registry study to evaluate the safety and performance of Floret(TM) Patent Ductus Arteriosus Occluder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MLS/Floret PDA Registry -1, V1.0.0 dated : 16-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 |
Both |
| Details |
Patients who underwent percutaneous, transcatheter
PDA closure using the Floret(TM) PDA Occluder |
|
| ExclusionCriteria |
| Details |
Patients who has not been treated with Floret(TM) PDA
Occluder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Successful PDA Closure
2.Incidence of adverse events and major complications
|
1. Time frame: Post procedure
2. Time frame: Upto discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Procedure time
2. Length of Hospital Stay
3.Ease of use
4.Incidence of adverse events and major complications |
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 |
|
|
Target Sample Size
|
Total Sample Size="245"
Sample Size from India="245"
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)
|
31/05/2025 |
| 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) |
Not Yet Recruiting |
|
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 Title: A retrospective, single-arm, multi-center, observational,
registry study to evaluate the safety and performance of
Floret™ Patent Ductus Arteriosus Occluder.
Indication: The Floret™ PDA Occluder is percutaneous, transcatheter
device especially designed for closure of normally located
patent 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 and
performance of Floret™ Patent Ductus Arteriosus Occluder
in 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 its
successful closure is critical to reducing associated risks such as chronic respiratory
diseases, pulmonary hemorrhage, and mortality. While various methods, including surgical
and transcatheter closure, have been used to treat PDA, there remains a need for a reliable
and minimally invasive option suitable for a broad range of patients, including those in the
very young pediatric population. The Floret™ Patent Ductus Arteriosus Occluder, a
percutaneous, 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 the
Floret™ PDA Occluder, providing valuable clinical data to support its use as an effective
treatment option for PDA closure. |