- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697359
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Odense, Denmark, 5000
- Odense University Hospital
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Novosibirsk, Russian Federation, 630055
- Academician E. N. Meshalkin
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Örebro, Sweden, 70185
- Orebro University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
There is only one group in this cohort study.
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The ILR will be implanted subcutaneous following standard surgical procedure.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of asymptomatic and symptomatic atrial fibrillation episodes
Time Frame: 12 months
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12 months
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Number of symptomatic and asymptomatic atrial fibrillation episodes
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Axel Brandes, MD, Odense University Hospital
Publications and helpful links
General Publications
- Bjorkenheim A, Brandes A, Magnuson A, Chemnitz A, Edvardsson N, Poci D. Patient-Reported Outcomes in Relation to Continuously Monitored Rhythm Before and During 2 Years After Atrial Fibrillation Ablation Using a Disease-Specific and a Generic Instrument. J Am Heart Assoc. 2018 Feb 24;7(5):e008362. doi: 10.1161/JAHA.117.008362.
- Bjorkenheim A, Brandes A, Chemnitz A, Magnuson A, Edvardsson N, Poci D. Rhythm Control and Its Relation to Symptoms during the First Two Years after Radiofrequency Ablation for Atrial Fibrillation. Pacing Clin Electrophysiol. 2016 Sep;39(9):914-25. doi: 10.1111/pace.12916. Epub 2016 Aug 5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AF-ABL-R-001
- S-20080066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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