ABLATOR Brazil - Ablation Observational Study (Registry)

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardioritmo Eletrofisiologia e Marpasso, Fortaleza, Ceará, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Pregnant women

Treatment and study plan

Observation / Data Collection

Other

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.

Primary outcomes

Unsuccessful Treatment Rate

Time frame: up to 6 and 12 months after ablation procedure

Percent of subjects with a repeat procedure

Secondary outcomes

Cardiovascular Serious Adverse Event (SAE)

Time frame: up to 6 and 12 months after ablation procedure

Percent of subjects with Cardiovascular SAE.
Death in Subjects Who Underwent an Ablation Procedure

Time frame: up to 12 months after ablation procedure

Percent of subjects experiencing death within 12 months of ablation procedure

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Feb 2, 2017
Registry last updated: Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed