A pacemaker study evaluating two algorithms for better pacing management
Phase 4
Completed
- Conditions
- Health Condition 1: null- Bradycardia
- Registration Number
- CTRI/2010/091/000179
- Lead Sponsor
- St Jude Medical Hong Kong Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1.Patients who have an indication for implantation of a dual chamber pacemaker according to the ACC / AHA / HRS guidelines
2.Patients must be able and willing to provide written informed consent to participate in the clinical study
3.Patient is geographically stable and willing to comply with the required follow-up schedule
Exclusion Criteria
1.Patient has permanent AV block
2.Patient has persistent or permanent AF/AFL
3.Patient has pacemaker replacement
4.Patient is in NYHA Class IV
5.Patient is pregnant
6.Patient is less than 18 years old
7.Patient?s life expectancy is less than 12 months.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that the Ventricular Intrinsic Preference (VIPTM) and Ventricular AutoCapture (VAC) features allow better RV pacing management, which helps in reducing the long-term incidence of unnecessary right ventricular (RV) pacing in patients with compromised / intact AV conduction.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method Incidence of AV blocks; Percentage of VAC accuracy in ventricular pacing threshold measurements (Manual vs. Auto);Incidence of cardiovascular adverse events;Incidence of device related adverse events; Proportion of patients with symptomsTimepoint: 3, 6 and 12 months