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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00697359
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):

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
Atrial Fibrillation Device: Implantable loop recorder (ILR)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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 : June 2008
Primary Completion Date : June 2015
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Number of asymptomatic and symptomatic atrial fibrillation episodes [ Time Frame: 12 months ]
  2. Number of symptomatic and asymptomatic atrial fibrillation episodes [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697359


Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Russian Federation
Academician E. N. Meshalkin
Novosibirsk, Russian Federation, 630055
Sweden
Örebro University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Axel Brandes, MD Odense University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Axel Brandes, Associate Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00697359     History of Changes
Other Study ID Numbers: AF-ABL-R-001
S-20080066
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Axel Brandes, Odense University Hospital:
Atrial fibrillation
Monitoring
Pulmonary vein isolation
Implantable loop recorder

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes