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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697359

Enrollment

Registered

2008-06-13

Start date

2008-06-30

Completion date

2016-06-30

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Monitoring, Pulmonary vein isolation, Implantable loop recorder

Brief summary

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.

Interventions

DEVICEImplantable loop recorder (ILR)

The ILR will be implanted subcutaneous following standard surgical procedure.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

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

* Atrial fibrillation episodes \> 3 months or permanent atrial fibrillation * No indication for pulmonary vein isolation * Contraindications for anticoagulation treatment * No informed consent

Design outcomes

Primary

Measure	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

Measure	Time frame
Number of asymptomatic and symptomatic atrial fibrillation episodes	12 months
Number of symptomatic and asymptomatic atrial fibrillation episodes	12 months

Countries

Denmark, Russia, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026