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Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00697359
Collaborator
(none)
57
Enrollment
3
Locations
1
Arm
96
Duration (Months)
19
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Implantable loop recorder (ILR)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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 Names:
  • All patients in the group get an ILR implanted.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring [12 months]

    Secondary Outcome Measures

    1. Number of asymptomatic and symptomatic atrial fibrillation episodes [12 months]

    2. Number of symptomatic and asymptomatic atrial fibrillation episodes [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000
    2 Academician E. N. Meshalkin Novosibirsk Russian Federation 630055
    3 Örebro University Hospital Örebro Sweden 70185

    Sponsors and Collaborators

    • Odense University Hospital

    Investigators

    • Principal Investigator: Axel Brandes, MD, Odense University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Axel Brandes, Associate Professor, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT00697359
    Other Study ID Numbers:
    • AF-ABL-R-001
    • S-20080066
    First Posted:
    Jun 13, 2008
    Last Update Posted:
    Sep 28, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Axel Brandes, Associate Professor, Odense University Hospital
    Atrial fibrillation
    Monitoring
    Pulmonary vein isolation
    Implantable loop recorder
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Sep 28, 2016