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ABLATOR Brazil - Ablation Observational Study (Registry)

NCT03041233 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 833

Last updated 2024-07-17

Study results available
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Summary

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).

Conditions

Interventions

OTHER

Observation / Data Collection

The following data will be reviewed / collected: Baseline Visit: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history. Ablation Procedure: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence). 6- and 12-month follow-up (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • André Luiz D'Avila · SOS Cardio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-13
Primary Completion
2020-04-27
Completion
2020-04-27

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041233 on ClinicalTrials.gov