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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00697359 |
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Date of registration:
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11/06/2008 |
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Primary sponsor: |
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Public title:
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Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
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Scientific title:
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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 |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00697359 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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Denmark
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Russian Federation
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Sweden
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Contacts
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Name:
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Axel Brandes, MD |
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Address:
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Telephone:
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+4565411896 |
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Email:
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axel.brandes@ouh.regionsyddanmark.dk |
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Affiliation:
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Name:
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Axel Brandes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Odense University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Intervention(s)
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Device: Implantable loop recorder (ILR)
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Primary Outcome(s)
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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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Secondary Outcome(s)
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Number of asymptomatic and symptomatic atrial fibrillation episodes
[Time Frame: 12 months]
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Number of symptomatic and asymptomatic atrial fibrillation episodes
[Time Frame: 12 months]
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Secondary ID(s)
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AF-ABL-R-001
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S-20080066
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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