| CTRI Number |
CTRI/2022/08/044935 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Medical Device Registry |
| Study Design |
Other |
|
Public Title of Study
|
To collect data of devices used during your ablation procedure |
|
Scientific Title of Study
|
EP Device Registry |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT04460209 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumit Anand |
| Designation |
Associate Director |
| Affiliation |
Abbott India Pvt. Ltd. |
| Address |
Plot No. 100, Ground Floor Okhla Industrial Estate Phase-III
New Delhi
DELHI
110020
India |
| Phone |
|
| Fax |
|
| Email |
sumit.anand@abbott.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumit Anand |
| Designation |
Associate Director |
| Affiliation |
Abbott India Pvt. Ltd. |
| Address |
Plot No. 100, Ground Floor Okhla Industrial Estate Phase-III
North East
DELHI
110020
India |
| Phone |
|
| Fax |
|
| Email |
sumit.anand@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumit Anand |
| Designation |
Associate Director |
| Affiliation |
Abbott India Pvt. Ltd. |
| Address |
Plot No. 100, Ground Floor Okhla Industrial Estate Phase-III
North East
DELHI
110020
India |
| Phone |
|
| Fax |
|
| Email |
sumit.anand@abbott.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abbott India Pvt Ltd |
| Address |
Dept. of Clinical Research, Plot No. 100, Ground Floor Okhla Industrial Estate Phase III, Delhi 110020 |
| Type of Sponsor |
Other [Medical Device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Austria
France
Germany
Hungary
India
Italy
Netherlands
Portugal
Spain |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balbir Singh |
Max Super Specialty Hospital |
1 2, Press Enclave
Marg, Saket
Institutional Area,
Saket, 110017
New Delhi
New Delhi
DELHI |
9810842890
drbalbirs@gmail.com |
| Dr NarayananNamboodiri |
Sree Chitra TirunalInstitute for MedicalSciences & Technology |
Jai Nagar W Rd,Chalakkuzhi, 695011
Thiruvananthapuram
KERALA |
9447223340
kknnamboodiri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Max Super Speciality Hospital |
Approved |
| Institutional Ethics Committee, SCTI |
Approved |
| Institutional Ethics Committee- CMC |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I498||Other specified cardiac arrhythmias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation procedure that used one or more Abbott devices covered by this Registry.
2. Subject is willing and able to comply with the site’s standard of care follow-up schedule. |
|
| ExclusionCriteria |
| Details |
1. Subject is currently participating in another clinical investigation that may confound the results of this Registry. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients with a device- and/or procedure-related Serious Adverse Event |
Reported within 7-days of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The proportion of procedures that achieved acute success. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="7500"
Sample Size from India="200"
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)
|
01/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/06/2020 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Publication details will be provided once available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
purpose of this registry is to collect medical information and experiences with
devices used during routine electrophysiology procedure. The registry will enroll 7,500 subjects across 20 or more sites
worldwide. Enrolled subject will be followed for 1year . This information will be used to confirm the safety, performance, and clinical benefits of these devices. |