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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/01/006492
• Date of registration: 07-01-2016
• Prospective Registration: No
• Primary sponsor: St Jude Medical India Pvt Ltd
• Public title: To evaluate the performance and effectiveness of SJM products in the treatment of subjects with atrial fibrillation.
• Scientific title: 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
• Date of first enrolment: 04-08-2015
• Target sample size: 1000
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=10230
• Study type: PMS
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Post Marketing Surveillance

Countries of recruitment

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

Contacts

• Name: Sumit Anand
• Affiliation: St. Jude Medical India Pvt. Ltd

• Name: Sumit Anand
• Affiliation: St. Jude Medical India Pvt. Ltd

Key inclusion & exclusion 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: Patient not willing to sign informed consent form

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients with Atrial Fibrillation

Intervention(s)

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

Primary Outcome(s)

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 Outcome(s)

To collect operator feedback on a combination of SJM productsTimepoint: 12 Months

Secondary ID(s)

CRD_723_Version A_17 Sep 2014

Source(s) of Monetary Support

St Jude Medical India Pvt Ltd No.1-11 250/A, Mata Rani sensation, Lane besides syndicate bank, Begumpet, Hyderabad 500016

Secondary Sponsor(s)

SJM International Inc

Ethics review

Status: Approved
Approval date: 19/02/2015
Contact:

Medanta Institutional Ethics Committee

Status: Approved
Approval date: 10/03/2015
Contact:

Independent Ethics Committee, Fortis Escorts Heart Institute

Status: Approved
Approval date: 12/03/2015
Contact:

Fortis Hospital Ethics Committee

Status: Approved
Approval date: 31/03/2015
Contact:

Institutional Ethics Committee

Results

• Date Completed: 18/08/2017