ABLATOR Brazil - Ablation Observational Study (Registry)

July 15, 2024 updated by: Abbott Medical Devices
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

833

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40050-410
        • Santa Casa de Misericórdia da Bahia
    • CE
      • Fortaleza, CE, Brazil
        • Cardioritmo Eletrofisiologia e Marpasso
    • DF
      • Brasília, DF, Brazil, 70200730
        • HOME - Hospital Ortopédico e Medicina Especializada LTDA.
    • ES
      • Vitória, ES, Brazil
        • Hospital Santa Rita
      • Vitória, ES, Brazil
        • Vitoria Apart Hotel
    • RJ
      • Rio de Janeiro, RJ, Brazil
        • Procardiaco
      • Volta Redonda, RJ, Brazil
        • Unimed de Volta Redonda
    • RS
      • Passo Fundo, RS, Brazil
        • Hospital São Vicente de Paulo
    • SC
      • Florianopolis, SC, Brazil
        • SOS Cardio
    • SP
      • São José do Rio Prêto, SP, Brazil
        • Insitituto de Moléstias Cardiovasculares - IMC
      • São Paulo, SP, Brazil
        • BP
      • São Paulo, SP, Brazil
        • SEMAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who are indicated for an atrial fibrillation ablation procedure, except for pregnant women.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unsuccessful Treatment Rate
Time Frame: up to 6 and 12 months after ablation procedure
Percent of subjects with a repeat procedure
up to 6 and 12 months after ablation procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Serious Adverse Event (SAE)
Time Frame: up to 6 and 12 months after ablation procedure
Percent of subjects with Cardiovascular SAE.
up to 6 and 12 months after ablation procedure
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
up to 12 months after ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: André Luiz D'Avila, SOS Cardio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2017

Primary Completion (Actual)

April 27, 2020

Study Completion (Actual)

April 27, 2020

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimated)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJM-CIP-10192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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