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

This study is currently recruiting participants.
Verified September 2011 by Odense University Hospital
Sponsor:
Information provided by (Responsible Party):
Axel Brandes, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00697359
First received: June 11, 2008
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention
Atrial Fibrillation
 Device: Implantable loop recorder (ILR)

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: June 2008
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697359

Contacts
Contact: Axel Brandes, MD +4565411896 ext 3646 axel.brandes@ouh.regionsyddanmark.dk

Locations
Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Axel Brandes, MD     +4565411896 ext 3646     axel.brandes@ouh.regionsyddanmark.dk    
Russian Federation
Academician E. N. Meshalkin Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Evgeny A. Pokushalov, MD, PhD            
Sweden
Örebro University Hospital Recruiting
Örebro, Sweden, 70185
Contact: Dritan Poci, MD     +46196021325        
Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Axel Brandes, MD Odense University Hospital
  More Information

No publications provided

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
Study First Received: June 11, 2008
Last Updated: September 2, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013