To evaluate the performance and effectiveness of SJM products in the treatment of subjects with atrial fibrillation.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients with Atrial Fibrillation
- Registration Number
- CTRI/2016/01/006492
- Lead Sponsor
- St Jude Medical India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2035
Inclusion Criteria
All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry.
Exclusion Criteria
Patient not willing to sign informed consent form
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm patient safety as part of the post market surveillance study. <br/ ><br>To assess performance of a combination of SJM products during procedures <br/ ><br>To assess the learning curve with a combination of SJM products. <br/ ><br>To collect operator feedback on a combination of SJM productsTimepoint: 12 Months
- Secondary Outcome Measures
Name Time Method To collect operator feedback on a combination of SJM productsTimepoint: 12 Months