A study of working of Dual Chamber Implantable Pacemaker.

Not Applicable

Completed

Conditions: Pacemakers are implanted in the patients having Bradycardia and heartâ€™s other electrical problems.

Registration Number: CTRI/2016/08/007165

Lead Sponsor: Shree Pacetronix Ltd

Brief Summary: | |

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|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 CHARAKâ€“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, CHARAKâ€“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.

Â·         Average pacing threshold (Atrium) was 1.05 Volt,

Â·         Average pacing threshold (Ventricle) was 1.07 Volt,

Â·         Average Impedance (Atrium) was 641.09 Ohms and

Â·         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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

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 5.2Â°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 â€œBeginning of Lifeâ€.

Exclusion Criteria

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.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Complication Rate: The criterion is that the complication rate should be less than 10% for acute phase (During Implantation & hospitalization).	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)
2. Pacing Threshold: It should be less than 2.0V @ 0.4ms Pulse Width.	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)
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): Postgraduate Institute of Medical Education and Research(PGIMER)
🇮🇳
Chandigarh, CHANDIGARH, India
Postgraduate Institute of Medical Education and Research(PGIMER)
🇮🇳Chandigarh, CHANDIGARH, India
Dr Yashpal Sharma
Principal investigator
pgimer-chd@nic.in