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Sponsored by: |
Odense University Hospital |
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Information provided by: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT00697359 |
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.
Condition | Intervention |
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Atrial Fibrillation |
Device: Implantable loop recorder (ILR) |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
There is only one group in this cohort study.
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Device: Implantable loop recorder (ILR)
The ILR will be implanted subcutaneous following standard surgical procedure.
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Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Axel Brandes, MD | +4565411896 ext 3646 | axel.brandes@ouh.regionsyddanmark.dk |
Denmark | |
Odense University Hospital | Recruiting |
Odense, Denmark, 5000 | |
Contact: Axel Brandes, MD +4565411896 ext 3646 axel.brandes@ouh.regionsyddanmark.dk | |
Aarhus University Hospital Aalborg | Recruiting |
Aalborg, Denmark, 9100 | |
Contact: Dritan Poci, MD +4599321111 |
Principal Investigator: | Axel Brandes, MD | Odense University Hospital |
Responsible Party: | Dept of Cardiology, Odense University Hospital ( Dr Axel Brandes, MD, Consultant in Cardiology ) |
Study ID Numbers: | AF-ABL-R-001, S-20080066 |
Study First Received: | June 11, 2008 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00697359 |
Health Authority: | Denmark: Danish Dataprotection Agency; Denmark: The Regional Committee on Biomedical Research Ethics |
Atrial fibrillation Monitoring Pulmonary vein isolation Implantable loop recorder |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |