ABLATOR Brazil - Ablation Observational Study (Registry)

NCT03041233 | Completed Results

• 1 other identifier: SJM-CIP-10192
• Study Type: observational
• Target: 833
• Locations: 1 country
• Sites: 12

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).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Unsuccessful Treatment Rate

  Percent of subjects with a repeat procedure

  up to 6 and 12 months after ablation procedure

Secondary Outcomes (2)

• Cardiovascular Serious Adverse Event (SAE)

  up to 6 and 12 months after ablation procedure

• Death in Subjects Who Underwent an Ablation Procedure

  up to 12 months after ablation procedure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (12)

Cardioritmo Eletrofisiologia e Marpasso

Fortaleza, Ceará, Brazil

Location

Hospital Santa Rita

Vitória, Espírito Santo, Brazil

Location

Vitoria Apart Hotel

Vitória, Espírito Santo, Brazil

Location

Santa Casa de Misericórdia da Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

Location

HOME - Hospital Ortopédico e Medicina Especializada LTDA.

Brasília, Federal District, 70200730, Brazil

Location

Procardiaco

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Unimed de Volta Redonda

Volta Redonda, Rio de Janeiro, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

SOS Cardio

Florianópolis, Santa Catarina, Brazil

Location

Insitituto de Moléstias Cardiovasculares - IMC

São José Do Rio Prêto, São Paulo, Brazil

Location

BP

São Paulo, São Paulo, Brazil

Location

SEMAP

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Observation; Data Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Clinical Scientist
• Organization: Abbott

emily.jesser@abbott.com

7639541350

Study Officials

• André Luiz D'Avila

  SOS Cardio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 2, 2017
• Study Start: April 13, 2017
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-07

Locations

BR (12)