Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation

Odense University Hospital

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Device: Implantable loop recorder (ILR)

Study type

Interventional

Funder types

Other

Identifiers

NCT00697359

S-20080066

AF-ABL-R-001

Details and patient eligibility

About

The primary aim of the study is to assess the efficacy of continuous rhythm monitoring with an implantable loop recorder (ILR) compared to conventional ambulatory electrocardiography in detecting episodes of atrial fibrillation after pulmonary vein isolation (PVI). The secondary aim is to assess the efficacy of PVI during a two years follow-up and to assess the reliability of the implantable loop recorder in detecting atrial fibrillation.

50 patients will be enrolled into the study. After enrollment an implantable loop recorder will be implanted at least 6 weeks before scheduled PVI. All patients will be followed for 24 months after PVI. During the follow-up period a 72-hours ambulatory electrocardiographic monitoring will be performed at 1, 6, 12, 18, and 24 months. Transthoracic echocardiography will be performed at enrollment, 3, 12, and 24 months after PVI. Moreover, quality of life will be assessed at baseline, and 6 and 12 months after PVI.

Enrollment

57 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age => 30 to =< 70 years
Documentation of paroxysmal atrial fibrillation
Documentation of persistent atrial fibrillation of < 3 months duration termination either spontaneously or by DC cardioversion
Scheduled pulmonary vein isolation
Treatment with at least one class IC or class III antiarrhythmic drug tried

Exclusion criteria