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CTRI Number  CTRI/2016/08/007165 [Registered on: 08/08/2016] Trial Registered Retrospectively
Last Modified On: 26/04/2019
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   A study of working of Dual Chamber Implantable Pacemaker. 
Scientific Title of Study   A clinical study for the safety and effectiveness of Dual Chamber Rate Responsive Implantable Pacemaker model CHARAK 747R. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CP01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yashpal Sharma 
Designation  M.D. D.M. 
Affiliation  PGIMER 
Address  Dept. of Cardiology, PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  ypspgi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yashpal Sharma 
Designation  MD DM 
Affiliation  PGIMER 
Address  Dept. of Cardiology, PGIMER Chandigarh
Dept. of Cardiology, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  ypspgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saurabh Mehrotra 
Designation  Asst. Professor Cardiology 
Affiliation  PGIMER 
Address  Dept. of Cardiology, PGIMER Chandigarh
Dept. of Cardiology, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  rhythm_divine46@yahoo.com  
 
Source of Monetary or Material Support  
Shree Pacetronix Ltd. 
 
Primary Sponsor  
Name  Shree Pacetronix Ltd 
Address  Sec-2 Plot no 15, Pithampur, Dist-Dhar M.P. Phone: 91-7292-411105 Fax: 91-7292-400418 Email: pacetronix@hotmail.com Website: www.pacetronix.com  
Type of Sponsor  Other [Pacemaker Manufacturing 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 
Dr Yashpal Sharma  Postgraduate Institute of Medical Education and Research(PGIMER)  Department of Cardiology Sector-12, Chandigarh PIN- 160012, INDIA.
Chandigarh
CHANDIGARH 		 0172-2756513

pgimer-chd@nic.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER, Chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pacemakers are implanted in the patients having Bradycardia and heart’s other electrical problems. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Charak 747R  Dual Chamber Rate Responsive Implantable Pacemaker model CHARAK 747R 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Fixed (third degree) AV block
2.Atrial Fibrillation with average Ventricular rate on ECG equal or less than than 40bpm or mean heart rate equal or less than 60bpm.
3.Sinus node Dysfunction with PR interval equal or greater than 300msec
4.Paroxysmal, persistent or permanent AF undergoing AV node , AV node/HIS ablation
5.2°AV Block with equal or greater than 3:1 block
6.The subject is 18 years of age or older
7.The subject has provided written consent for the Pacemaker procedure.
8.Pre-existing Cardiac Permanent pacemaker showing “Beginning of Life”. 
 
ExclusionCriteria 
Details  1.Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
2.Presence of Hypertrophic Obstructive Cardiomyopathy
3.Recent cardiac surgery (equal or less than 30 days)
4.Recent myocardial infarction (equal or less than 30 days)
5.Presence of mechanical prosthetic tricuspid valve
6.Current or planned pregnancy in the next 6 months.
7.Patients with life expectancy less than 6 months.
8.chronic renal failure 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Complication Rate: The criterion is that the complication rate should be less than 10% for acute phase (During Implantation & hospitalization).
2. Pacing Threshold: It should be less than 2.0V @ 0.4ms Pulse Width.
3. Lead Impedance: It should be between 300 to 1000 ohms.

 		 1. Complication Rate: acute phase (During Implantation & hospitalization).
2. Pacing Threshold: After 6 months of implant.
3. Lead Impedance: It should be between 300 to 1000 ohms.
(After 3 months of implant)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Rate based on activity: The device should show change in rate based on activity as per parameters settings.
2. Anti Tachy therapy (AT): In case of atrial tachycardia the ventricle should stop following atrium and it should come down to base rate. It should not show any inappropriate response.
3. AV Hysteresis: If AV Hysteresis is ON then if R-wave is frequently appearing then pacer should show less percentages of pacing in ventricle. It should not show any inappropriate response.
 		 It will checked after 3 months of implant.
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   05/02/2016 
Date of Study Completion (India) 30/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This is a Prospective, Controlled, single center clinical study.

Objective of the Clinical study is to assess the safety and clinical performance of the device and to evaluate whether the device is suitable for the purpose(s) and the population(s) for which it is intended.

Conclusion: - The study was conducted on 35 patients, who were implanted with CHARAK–DDDR 747R, dual chamber rate responsive pacemaker.Study was completed at the end of 18 month of follow up on these patients. There was no instance of adverse event reported in any of the patients because of the device.As per the study, CHARAK–DDDR 747R, dual chamber pacemaker is safe and effective treatment for patients.

Out of the selected 35 patients, 45.71 % were male and 54.29 % were female, with average age of 62 years, 85 years being the oldest and 47 years as the youngest patient.

·         Average pacing threshold (Atrium) was 1.05 Volt,

·         Average pacing threshold (Ventricle) was 1.07 Volt,

·         Average Impedance (Atrium) was 641.09 Ohms and

·         Average Impedance (Ventricle) was 719.31 Ohms.

Appropriate increase of rate during activity and an appropriate rate decrease following the cessation of activity in the DDDR pacing mode was noted. There were no events of unexpected sensor behaviour during any activity or sensor parameter optimizations.

During required follow-up evaluations, there were no complications resulting from inappropriate patient-pulse generator interaction or device malfunction as reported by the investigator. There was only one death reported and thatis not attributed to the device, as certified by the doctor.

Interaction of programming system (SMART E Interface & Programming head) and SPL software with the CHARAK DDDR Model 747R including interrogation, programming and use of other features was reliable. The diagnostic feature of software was very useful to detect the correct status of implant lead & pacemaker. 


 
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