| CTRI Number |
CTRI/2022/04/042267 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
28/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TRIAL FOR EVALUATING THE EFFICACY OF A NEW LEADLESS DEFIBRILLATOR SYSTEM |
|
Scientific Title of Study
|
ACUTE EVALUATION OF A NOVEL LEADLESS DEFIBRILLATOR SYSTEM |
| Trial Acronym |
CT-06 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr V Nandakumar |
| Designation |
Director and Chief-Division of Cardio Vascular Thoracic Surgery |
| Affiliation |
Metromed International Cardiac Centre |
| Address |
Metromed International Cardiac Centre,Thondayad Bypass Road, Calicut, Kerala
Kozhikode
KERALA
673014
India |
| Phone |
|
| Fax |
|
| Email |
prof.nandakumarv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prathap Vasu C |
| Designation |
DIRECTOR |
| Affiliation |
Innovitae Clinical Research Services Pvt Ltd |
| Address |
Innovitae Clinical Research Services Pvt Ltd
Manyata Embassy Business Park,Ground Floor, E1 Block, Beech Building, Outer Ring Road, Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
prathap.vc@innovitae.in |
|
Details of Contact Person
Public Query
|
| Name |
Apurv Swarup |
| Designation |
Consultant |
| Affiliation |
CALYAN CARDIAC THERAPEUTICS INDIA LIMITED |
| Address |
B-15, 2nd street, Ambattur industrial estate, Ambattur, Chennai
Chennai
TAMIL NADU
600058
India |
| Phone |
|
| Fax |
|
| Email |
apurv@calyantech.com |
|
|
Source of Monetary or Material Support
|
| CALYAN CARDIAC THERAPEUTICS INDIA PVT LTD, B-15, 2nd street, Ambattur industrial estate, Ambattur, Chennai 600058, Tamil Nadu , INDIA |
|
|
Primary Sponsor
|
| Name |
CALYAN CARDIAC THERAPEUTICS INDIA PVT LTD |
| Address |
B-15, 2nd street, Ambattur industrial estate, Ambattur, Chennai 600058, Tamil Nadu , INDIA |
| Type of Sponsor |
Other [Medical Device] |
|
|
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 |
| Prof Dr V Nandakumar |
Metromed International Cardiac Centre |
Division of Cardio Vascular Thoracic surgery and Heart Transplanataion, Thondayad Bypass Road, Calicut, Kerala 673014 Kozhikode KERALA
Kozhikode
Kozhikode
KERALA |
8592851444
prof.nandakumarv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,,Metromed International Cardiac Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I279||Pulmonary heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calyan Leadless Defibrillator System |
The device being studied is a investigational device. The device will contain two
FlexArm electrodes connected to an externalized lead with a DF-4 connector, which can
be connected to an external defibrillator or implantable cardioverter defibrillator (ICD)
pulse generator to provide defibrillation shocks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Female or male
2. Age 18 or above
3. Willing and capable of providing informed consent
4. Scheduled for ICD implantation |
|
| ExclusionCriteria |
| Details |
1. Patients with have previously undergone an open heart surgical procedure
2. Currently implanted with a cardiac pacemaker, implantable cardioverter
defibrillator, cardiac resynchronization, or neurostimulation device |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy endpoint will be the number of patients with successful
defibrillation of the ventricle with the leadless defibrillation system. |
VISIT 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secconary endpoint will be the number of patients with successful
defibrillation of the ventricle with the leadless defibrillation system. |
Visit 2 |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
10/05/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is A prospective, multi-site, single-arm, open-label feasibility study. This study is designed to evaluate the efficacy implant procedure and placement of the Calyan leadless defibrillator, and to evaluate the feasibility of defibrillation.Subjects Scheduled for ICD implantation will be recruited in the study.The device will be connected to anexternal defibrillator or ICD pulse generator, and defibrillation testing (ventricularfibrillation induction and cardioversion) will be performed.
The data from this study will be used to refine the device design, and to justify further investigation of the leadless defibrillation system. |