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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

There is only one group in this cohort study.

Group Type EXPERIMENTAL

Implantable loop recorder (ILR)

Intervention Type DEVICE

The ILR will be implanted subcutaneous following standard surgical procedure.

Interventions

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Implantable loop recorder (ILR)

The ILR will be implanted subcutaneous following standard surgical procedure.

Intervention Type DEVICE

Other Intervention Names

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All patients in the group get an ILR implanted.

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No