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

Not Applicable
Completed
Conditions
Atrial Fibrillation
Interventions
Device: Implantable loop recorder (ILR)
Registration Number
NCT00697359
Lead Sponsor
Odense University Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
57
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
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Exclusion Criteria
  • Atrial fibrillation episodes > 3 months or permanent atrial fibrillation
  • No indication for pulmonary vein isolation
  • Contraindications for anticoagulation treatment
  • No informed consent
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Implantable loop recorder (ILR)There is only one group in this cohort study.
Primary Outcome Measures
NameTimeMethod
Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring12 months
Secondary Outcome Measures
NameTimeMethod
Number of asymptomatic and symptomatic atrial fibrillation episodes12 months
Number of symptomatic and asymptomatic atrial fibrillation episodes12 months

Trial Locations

Locations (3)

Odense University Hospital

🇩🇰

Odense, Denmark

Örebro University Hospital

🇸🇪

Örebro, Sweden

Academician E. N. Meshalkin

🇷🇺

Novosibirsk, Russian Federation

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