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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Odense University Hospital
- Enrollment
- 57
- Locations
- 3
- Primary Endpoint
- Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Axel Brandes
Associate Professor
Odense University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
- Number of asymptomatic and symptomatic atrial fibrillation episodes(12 months)
- Number of symptomatic and asymptomatic atrial fibrillation episodes(12 months)