CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 833 enrolled
Drug / intervention
Observation / Data Collectionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT03041233N/ACompleted
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ABLATOR Brazil - Ablation Observational Study (Registry)

Abbott Medical Devices·observational·Posted Feb 2, 2017·Updated Jul 17, 2024

In Brief

An observational study evaluating Observation / Data Collection for Atrial Fibrillation. Completed, enrolled 833 participants across 12 sites.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2, 2017
Enrollment StartApr 13, 2017
Primary CompletionApr 27, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.4 years ago

Interventions

Observation / Data Collectionother

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.