ABLATOR Brazil - Ablation Observational Study (Registry)

Atrial Fibrillation Clinical Trial

Official title:

ABLATOR Brazil - Ablation Observational Study (Registry)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03041233
• Other study ID #: SJM-CIP-10192
• Status: Active, not recruiting
• Start date: April 13, 2017
• Est. completion date: April 27, 2020

Study information

• Verified date: September 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 833
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unsuccessful treatment rate, measured by the number of repeated procedure	measured by the number of repeated procedure	within 12 months after ablation procedure
Secondary	Cardiovascular Serious Adverse Event	Reporting of SAE through the CRF	within 12 months after ablation procedure
Secondary	Death	Reporting of death through the CRF	within 12 months after ablation procedure