To evaluate the performance and effectiveness of SJM products in the treatment of subjects with atrial fibrillation.

To assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation. - ABLATOR Ablation Observational Registry

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/01/006492

Enrollment

1000

Registered

2016-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with Atrial Fibrillation

Interventions

Intervention1: atrial fibrillation ablation & diagnostic catheters: Patient indicated for an atrial fibrillation ablation procedure with SJM commercially available products. Control Intervention1: Not

Eligibility

Inclusion criteria

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

Exclusion criteria: Patient not willing to sign informed consent form

Design outcomes

Primary

Measure	Time frame
To confirm patient safety as part of the post market surveillance study. To assess performance of a combination of SJM products during procedures To assess the learning curve with a combination of SJM products. To collect operator feedback on a combination of SJM productsTimepoint: 12 Months	—

Secondary

Measure	Time frame
To collect operator feedback on a combination of SJM productsTimepoint: 12 Months	—

Countries

Austria, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Netherlands, Portugal, Saudi Arabia, Spain, United Kingdom

Contacts

Public ContactSumit Anand

St. Jude Medical India Pvt. Ltd

sanand@sjm.com91-11-42600161

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026