Atrial FibrillationNCT00697359
Implantable Loop Recorder Versus Conventional Ambulatory Monitoring in Detecting Atrial Fibrillation After Pulmonary Vein Isolation
A study testing Implantable loop recorder (ILR) in people with Atrial Fibrillation, run by Odense University Hospital at 3 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Implantable loop recorder (ILR)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2008to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Atrial fibrillation episodes > 3 months or permanent atrial fibrillation
- No indication for pulmonary vein isolation
- Contraindications for anticoagulation treatment
- No informed consent
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Implantable loop recorder (ILR)
- Keywords
- Atrial fibrillation, Monitoring, Pulmonary vein isolation, Implantable loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable loop recorder (ILR)Device
Also called All patients in the group get an ILR implanted.
The ILR will be implanted subcutaneous following standard surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | There is only one group in this cohort study. Receives: Device: Implantable loop recorder (ILR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with atrial fibrillation detected by implantable loop recorder and number of patients with atrial fibrillation detected by conventional ambulatory electrocardiographic monitoring
Measured: 12 months
Secondary outcomes (2)
Number of asymptomatic and symptomatic atrial fibrillation episodes
Measured: 12 months
Number of symptomatic and asymptomatic atrial fibrillation episodes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Brandes, Odense University Hospital
- Investigators
- Axel Brandes, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697359
- Sponsor's protocol ID
- AF-ABL-R-001
- Other IDs
- S-20080066
- Status last verified
- Sep 2016
- First submitted
- 11 Jun 2008
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29478027Bjorkenheim 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.
PubMed 27418324
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00697359
- Acronym / sponsor ID
- AF-ABL-R-001
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Monitoring, Pulmonary vein isolation, Implantable loop recorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Implantable loop recorder (ILR)There is only one group in this cohort study. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Atrial fibrillation episodes > 3 months or permanent atrial fibrillation
- No indication for pulmonary vein isolation
- Contraindications for anticoagulation treatment
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable loop recorder (ILR)Also: All patients in the group get an ILR implanted.The ILR will be implanted subcutaneous following standard surgical procedure. | Device | 1 |
Primary outcome
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
2 secondary outcomes
Number of asymptomatic and symptomatic atrial fibrillation episodes
Time frame: 12 months
Number of symptomatic and asymptomatic atrial fibrillation episodes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 29478027Bjorkenheim 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.
- Derived from this study: PubMed 27418324Bjorkenheim 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Brandes, MD principal investigator
Odense University Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable loop recorder (ILR) in people with Atrial Fibrillation, run by Odense University Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Russia, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00697359, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.