"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01164319

AFERAWCLP-022

RU AF 002 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• highly symptomatic patients refractory to at least two antiarrhythmic drugs
• patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.

Exclusion criteria

• congestive heart failure
• ejection fraction <35%
• left atrial diameter >60 mm
• previous ablation procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 4 patient groups

Group 1 (no early recurrence)

Active Comparator group

Description:

Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.

Treatment:

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Group 2 (early AF recurrence)

Active Comparator group

Description:

Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.

Treatment:

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Group 3 (early recurrence-no reablation)

Active Comparator group

Description:

Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.

Treatment:

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

Group 4 (early recurrence-early reablation)

Active Comparator group

Description:

Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor.

Treatment:

Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation