Clinical trial NCT00697359: 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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Monitoring
Pulmonary vein isolation
Implantable loop recorder
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2008-06-13
Enrollment: 57
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
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
timeFrame: 12 months
Secondary outcomes:
measure: Number of asymptomatic and symptomatic atrial fibrillation episodes
timeFrame: 12 months
measure: Number of symptomatic and asymptomatic atrial fibrillation episodes
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Novosibirsk
country: Russian Federation
facility: Academician E. N. Meshalkin
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Odense University Hospital
name: Axel Brandes, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.