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CTRI Number  CTRI/2019/07/020173 [Registered on: 15/07/2019] Trial Registered Prospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A STUDY TO ASSES THE EFFICACY OF A LEADLESS PACEMAKER SYSTEM 
Scientific Title of Study   Acute Evaluation of a Novel Leadless Pacemaker System 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-01 Version No:01 25 JUNE 2019  Protocol Number 
 
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  
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  Manyata Embassy Business Park,Ground Floor, E1 Block, Beech Building, Outer Ring Road, Bangalore

Bangalore
KARNATAKA
560045
India 
Phone  9400144281  
Fax    
Email  prathap.vc@innovitae.in  
 
Details of Contact Person
Public Query  
Name  Apurv Swarup 
Designation  CONSULTANT 
Affiliation  Calyan Cardiac Therapeutics India Pvt Ltd 
Address  B-15, 2nd street, Ambattur industrial estate, Ambattur, Chennai

Chennai
TAMIL NADU
600058
India 
Phone  9654803618  
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 
Type of Sponsor  Other [MEDICAL DEVICE COMPANY] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 		 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CALYAN LEADLESS PACEMAKER  The Calyan leadless pacemaker system is an investigational device for the treatment of cardiac disorders requiring ventricular pacing. The principal components of the Calyan pacemaker system are an implantable pulse generator, a delivery system, and an external programming system.The Calyan Leadless Pacemaker contains a Clip which is designed to attach to the end of the xiphoid process. The Can is positioned underneath the ribcage, and the FlexArm extends towards the heart, with the electrodes placed in direct contact with the pericardium. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Scheduled to undergo a non-emergency open heart surgical procedure.
2.Willing and capable of providing informed consent 
 
ExclusionCriteria 
Details  1.Patients who are not anatomically suitable to receive a sub-xiphoidal implant
2.Patients who have previously undergone an open heart surgical procedure
3.Currently implanted with a cardiac pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization device
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The number of patients with successful implantation of the leadless pacemaker. Successful implantation will be judged by the mechanical placement of the device under the xiphoid process using the insertion tool.  After temporary implantation of the Calyan Leadless Pacemaker 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary efficacy endpoint will be the number of patients with successful pacing of the ventricle with the leadless pacemaker system.   After Anatomical measurements and ventricular electrogram  
 
Target Sample Size   Total Sample Size="5"
Sample Size from India="5" 
Final Enrollment numbers achieved (Total)= "5"
Final Enrollment numbers achieved (India)="5" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   16/07/2019 
Date of Study Completion (India) 05/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The primary study objective is to validate the implant procedure and placement of the Calyan pacemaker.The device being studied is  mechanically designed to be inserted and clipped to the xiphoid process.The pacemaker delivery system will be the design intended for chronic human use, and the pacemaker will be pre-loaded in the delivery system in a sterile package.This study is designed to evaluate the implant procedure and placement of the Calyan leadless pacemaker. The data from this study will be used to refine the implant procedure and device design, and to justify further investigation of the leadless pacemaker system.

Study Design: 
This is an Open-label feasibility study.Following enrollment, each patient will participate in a temporary implantation and removal procedure that will last less than 1 hour. The leadless pacemaker device will be temporarily implanted in patients who is undergoing non emergency open heart surgery. The device will be inserted underneath the ribcage and temporarily clipped to the underside of the xiphoid process, with electrodes placed in an appropriate position on the cardiac surface. The device will be connected to a clinical stimulator through an external lead. Anatomical measurements will be made, a ventricular electrogram will be recorded, and pacing threshold will be determined.

Performance and Safety Evaluations:

The primary safety endpoint will be the incidence of procedure and device-related complications.

The primary efficacy endpoint will be the number of patients with successful implantation of the leadless pacemaker. Successful implantation will be judged by the mechanical placement of the device under the xiphoid process using the insertion tool.

The secondary efficacy endpoint will be the number of patients with successful pacing of the ventricle with the leadless pacemaker system.

Study Procedures: 

The leadless pacemaker device will be temporarily implanted in patients who are schdeuled for a non-emergency open heart surgery using the following procedure: with the patient lying on their back, an incision will be made in the chest, just below the xiphoid process. The device will be inserted underneath the ribcage and temporarily clipped to the underside of the xiphoid process. The electrodes will be placed in an appropriate position on the cardiac surface. The device will be connected to a clinical stimulator through an external lead. Anatomical measurements will be made, a ventricular electrogram will be recorded, and pacing threshold will be determined.





 
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