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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697359
• Other study ID #: AF-ABL-R-001
• Secondary ID: S-20080066
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: September 27, 2016
• Start date: June 2008
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Implantable loop recorder (ILR)
The ILR will be implanted subcutaneous following standard surgical procedure.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense
Russian Federation	Academician E. N. Meshalkin	Novosibirsk
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Countries where clinical trial is conducted

Denmark,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring		12 months	No
Secondary	Number of asymptomatic and symptomatic atrial fibrillation episodes		12 months	No
Secondary	Number of symptomatic and asymptomatic atrial fibrillation episodes		12 months	No