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

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Study to Assess the Efficacy of Continuous Subcutaneous Arrhythmia Monitoring Versus Conventional Ambulatory ECG-monitoring in Detecting Atrial Fibrillation in Patients After Pulmonary Vein Isolation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Implantable loop recorder (ILR)


Participation Criteria
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Eligibility Criteria
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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: Atrial fibrillation episodes > 3 months or permanent atrial fibrillation No indication for pulmonary vein isolation Contraindications for anticoagulation treatment No informed consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>There is only one group in this cohort study. | Device: Implantable loop recorder (ILR)<br>* The ILR will be implanted subcutaneous following standard surgical procedure.<br>* Other names: All patients in the group get an ILR implanted.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of asymptomatic and symptomatic atrial fibrillation episodes |  | 12 months | 
| Number of symptomatic and asymptomatic atrial fibrillation episodes |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Monitoring, Pulmonary vein isolation, Implantable loop recorder