NCT00697359

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

7 years

First QC Date

June 11, 2008

Last Update Submit

September 27, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationMonitoringPulmonary vein isolationImplantable loop recorder

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of asymptomatic and symptomatic atrial fibrillation episodes

    12 months

  • Number of symptomatic and asymptomatic atrial fibrillation episodes

    12 months

Study Arms (1)

1

EXPERIMENTAL

There is only one group in this cohort study.

Device: Implantable loop recorder (ILR)

Interventions

Implantable loop recorder (ILR)DEVICE

The ILR will be implanted subcutaneous following standard surgical procedure.

Also known as: All patients in the group get an ILR implanted.
1

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Atrial fibrillation episodes \> 3 months or permanent atrial fibrillation
  • No indication for pulmonary vein isolation
  • Contraindications for anticoagulation treatment
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Odense University Hospital

Odense, 5000, Denmark

Location

Academician E. N. Meshalkin

Novosibirsk, 630055, Russia

Location

Örebro University Hospital

Örebro, 70185, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 29478027DERIVED

  • 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.

    PMID: 27418324DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Axel Brandes, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 13, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

September 28, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)SE(1)RU(1)