Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation 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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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|
- 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 ] [ Designated as safety issue: No ]
- Number of asymptomatic and symptomatic atrial fibrillation episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of symptomatic and asymptomatic atrial fibrillation episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
There is only one group in this cohort study.
Device: Implantable loop recorder (ILR)
The ILR will be implanted subcutaneous following standard surgical procedure.
Other Name: All patients in the group get an ILR implanted.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697359
|Odense University Hospital|
|Odense, Denmark, 5000|
|Academician E. N. Meshalkin|
|Novosibirsk, Russian Federation, 630055|
|Örebro University Hospital|
|Örebro, Sweden, 70185|
|Principal Investigator:||Axel Brandes, MD||Odense University Hospital|