ABLATOR Brazil - Ablation Observational Study (Registry)
NCT ID: NCT03041233
Last Updated: 2024-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
833 participants
OBSERVATIONAL
2017-04-13
2020-04-27
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Observation / Data Collection
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
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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André Luiz D'Avila
Role: PRINCIPAL_INVESTIGATOR
SOS Cardio
Locations
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Cardioritmo Eletrofisiologia e Marpasso
Fortaleza, Ceará, Brazil
Hospital Santa Rita
Vitória, Espírito Santo, Brazil
Vitoria Apart Hotel
Vitória, Espírito Santo, Brazil
Santa Casa de Misericórdia da Bahia
Salvador, Estado de Bahia, Brazil
HOME - Hospital Ortopédico e Medicina Especializada LTDA.
Brasília, Federal District, Brazil
Procardiaco
Rio de Janeiro, Rio de Janeiro, Brazil
Unimed de Volta Redonda
Volta Redonda, Rio de Janeiro, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
SOS Cardio
Florianópolis, Santa Catarina, Brazil
Insitituto de Moléstias Cardiovasculares - IMC
São José Do Rio Prêto, São Paulo, Brazil
BP
São Paulo, São Paulo, Brazil
SEMAP
São Paulo, São Paulo, Brazil
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10192
Identifier Type: -
Identifier Source: org_study_id
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