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OpenTrials
Completed

NCT Number: NCT00697359

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Odense, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Loop Recorder (ILR)

Device

The ILR will be implanted subcutaneous following standard surgical procedure.

Other names: All patients in the group get an ILR implanted.

Primary outcomes

  1. 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

  1. Number of asymptomatic and symptomatic atrial fibrillation episodes

    Time frame: 12 months

  2. Number of symptomatic and asymptomatic atrial fibrillation episodes

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2015
Study completion
2016
First posted
Jun 13, 2008
Registry last updated
Sep 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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