ABLATOR Brazil - Ablation Observational Study (Registry)

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT03041233
• Lead Sponsor: Abbott Medical Devices

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-02
• Study Start: 2017-04-13
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Results First Submitted: 2023-06-12
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Results First Posted: 2024-07-17
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 833

Inclusion Criteria

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

Exclusion Criteria

• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Unsuccessful Treatment Rate	up to 6 and 12 months after ablation procedure	Percent of subjects with a repeat procedure

Secondary Outcome Measures

Name	Time	Method
Death in Subjects Who Underwent an Ablation Procedure	up to 12 months after ablation procedure	Percent of subjects experiencing death within 12 months of ablation procedure
Cardiovascular Serious Adverse Event (SAE)	up to 6 and 12 months after ablation procedure	Percent of subjects with Cardiovascular SAE.

Trial Locations

Locations (12)

Procardiaco; 🇧🇷 Rio de Janeiro, RJ, Brazil

Unimed de Volta Redonda; 🇧🇷 Volta Redonda, RJ, Brazil

Vitoria Apart Hotel; 🇧🇷 Vitória, ES, Brazil

SEMAP; 🇧🇷 São Paulo, SP, Brazil

Cardioritmo Eletrofisiologia e Marpasso; 🇧🇷 Fortaleza, CE, Brazil

HOME - Hospital Ortopédico e Medicina Especializada LTDA.; 🇧🇷 Brasília, DF, Brazil

Hospital Santa Rita; 🇧🇷 Vitória, ES, Brazil

SOS Cardio; 🇧🇷 Florianopolis, SC, Brazil

Insitituto de Moléstias Cardiovasculares - IMC; 🇧🇷 São José do Rio Prêto, SP, Brazil

Hospital São Vicente de Paulo; 🇧🇷 Passo Fundo, RS, Brazil

BP; 🇧🇷 São Paulo, SP, Brazil

Santa Casa de Misericórdia da Bahia; 🇧🇷 Salvador, Bahia, Brazil