A study of working of Dual Chamber Implantable Pacemaker.

Phase 4

Completed

• Conditions: Health Condition 1: null- 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

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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

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