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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Axel Brandes, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00697359
First received: June 11, 2008
Last updated: November 28, 2013
Last verified: November 2013

June 11, 2008
November 28, 2013
June 2008
January 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00697359 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
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

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Atrial Fibrillation
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.
Experimental: 1
There is only one group in this cohort study.
Intervention: Device: Implantable loop recorder (ILR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
January 2016
January 2015   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Denmark,   Sweden
 
NCT00697359
AF-ABL-R-001, S-20080066
No
Axel Brandes, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Axel Brandes, MD Odense University Hospital
Odense University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP