Clinical trial NCT03041233: ABLATOR Brazil - Ablation Observational Study (Registry)
Official title: ABLATOR Brazil - Ablation Observational Study (Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-02-02
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who are indicated for an atrial fibrillation ablation procedure, except for pregnant women.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Unsuccessful Treatment Rate
timeFrame: up to 6 and 12 months after ablation procedure
Secondary outcomes:
measure: Cardiovascular Serious Adverse Event (SAE)
timeFrame: up to 6 and 12 months after ablation procedure
measure: Death in Subjects Who Underwent an Ablation Procedure
timeFrame: up to 12 months after ablation procedure
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Santa Casa de Misericórdia da Bahia
state: Bahia
city: Fortaleza
country: Brazil
facility: Cardioritmo Eletrofisiologia e Marpasso
state: CE
city: Brasília
country: Brazil
facility: HOME - Hospital Ortopédico e Medicina Especializada LTDA.
state: DF
city: Vitória
country: Brazil
facility: Hospital Santa Rita
state: ES
city: Vitória
country: Brazil
facility: Vitoria Apart Hotel
state: ES
city: Rio de Janeiro
country: Brazil
facility: Procardiaco
state: RJ
city: Volta Redonda
country: Brazil
facility: Unimed de Volta Redonda
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: RS
city: Florianopolis
country: Brazil
facility: SOS Cardio
state: SC
city: São José do Rio Prêto
country: Brazil
facility: Insitituto de Moléstias Cardiovasculares - IMC
state: SP
city: São Paulo
country: Brazil
facility: BP
state: SP
city: São Paulo
country: Brazil
facility: SEMAP
state: SP
Study officials:
affiliation: SOS Cardio
name: André Luiz D'Avila
role: PRINCIPAL_INVESTIGATOR
References: