Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment implantable loop recorder (ilr)
Sponsor Odense University Hospital
Start date June 2008
End date January 2015
Trial size 50 participants
Trial identifier NCT00697359, AF-ABL-R-001, S-20080066

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
There is only one group in this cohort study.
implantable loop recorder (ilr) All patients in the group get an ILR implanted.
The ILR will be implanted subcutaneous following standard surgical procedure.

Primary Outcomes

Measure
Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring
time frame: 12 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title 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
Principal investigator Axel Brandes, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Odense University Hospital.