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ABLATOR Brazil - Ablation Observational Study (Registry)

Abbott logo

Abbott

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: Observation / Data Collection

Study type

Observational

Funder types

Industry

Identifiers

NCT03041233
SJM-CIP-10192

Details and patient eligibility

About

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of St. Jude Medical (SJM)/Abbott mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Full description

The objectives of this registry are the following:

  • 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 products.

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.

In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Enrollment

833 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion criteria

  • Pregnant women

Trial design

Trial documents
1

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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