Health Condition 1: null- Pacemakers are implanted in the patients having Bradycardia and heartâ??s other electrical problems.
Conditions
Interventions
Intervention1: Model name Charak 747R: Dual Chamber Rate Responsive Implantable Pulse Generator
Intervention2: NIL: NIL
Control Intervention1: Charak 747R: Dual Chamber Rate Responsive Implantable Pac
Sponsors
Shree Pacetronix Ltd
Eligibility
Inclusion criteria
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 5.2°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 â??Beginning of Lifeâ??.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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
| Measure | Time frame |
|---|---|
| 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. Timepoint: It will checked after 3 months of implant. | — |
Countries
India
Contacts
Public ContactDr Saurabh Mehrotra
PGIMER
Outcome results
None listed