Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantable loop recorder (ILR)
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Monitoring, Pulmonary vein isolation, Implantable loop recorder
Eligibility 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
Sites / Locations
- Odense University Hospital
- Academician E. N. Meshalkin
- Örebro University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
There is only one group in this cohort study.
Outcomes
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
Secondary Outcome Measures
Number of asymptomatic and symptomatic atrial fibrillation episodes
Number of symptomatic and asymptomatic atrial fibrillation episodes
Full Information
NCT ID
NCT00697359
First Posted
June 11, 2008
Last Updated
September 27, 2016
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00697359
Brief Title
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Monitoring, Pulmonary vein isolation, Implantable loop recorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
There is only one group in this cohort study.
Intervention Type
Device
Intervention Name(s)
Implantable loop recorder (ILR)
Other Intervention Name(s)
All patients in the group get an ILR implanted.
Intervention Description
The ILR will be implanted subcutaneous following standard surgical procedure.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Number of asymptomatic and symptomatic atrial fibrillation episodes
Time Frame
12 months
Title
Number of symptomatic and asymptomatic atrial fibrillation episodes
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Brandes, MD
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Academician E. N. Meshalkin
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29478027
Citation
Bjorkenheim A, Brandes A, Magnuson A, Chemnitz A, Edvardsson N, Poci D. Patient-Reported Outcomes in Relation to Continuously Monitored Rhythm Before and During 2 Years After Atrial Fibrillation Ablation Using a Disease-Specific and a Generic Instrument. J Am Heart Assoc. 2018 Feb 24;7(5):e008362. doi: 10.1161/JAHA.117.008362.
Results Reference
derived
PubMed Identifier
27418324
Citation
Bjorkenheim A, Brandes A, Chemnitz A, Magnuson A, Edvardsson N, Poci D. Rhythm Control and Its Relation to Symptoms during the First Two Years after Radiofrequency Ablation for Atrial Fibrillation. Pacing Clin Electrophysiol. 2016 Sep;39(9):914-25. doi: 10.1111/pace.12916. Epub 2016 Aug 5.
Results Reference
derived
Learn more about this trial
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
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