Sleep Disordered BreathingNCT02727192
Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation
A study testing PAP (CPAP or ASV) in people with Sleep Disordered Breathing and Sleep Apnea, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades. The occurrence of AF is associated with significantly increased mortality as well as morbidity of which cerebrovascular accidents is the most important. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Disordered Breathing, Sleep Apnea, Paroxysmal Atrial Fibrillation
- What is being tested?
- PAP (CPAP or ASV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteNorway
- Study dates
- 21 Jan 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Male or female
- Patients with paroxysmal AF scheduled for first or second catheter ablation
- Moderate-to-severe SA defined as an AHI ≥15/h (OSA and/or CSA)
- Signed informed consent
Who cannot join
- Unstable patients
- Patients with left ventricular ejection fraction (LV-EF) < 45%
- Unstable coronary artery disease, myocardial infarction or PCI within 3 months prior to the study
- Bypass surgery within 6 months prior to the study
- Patients with TIA or stroke within the previous 3 months
- BMI > 40kg/m2
Show all 13Show fewer
- Drowsy drivers and/or sleepy patients with ESS (Epworth Sleepiness Score) > 15
- Patients with interstitial lung diseases, severe obstructive lung defects, and thoracic myopathies or severe obstructive lung defects with FEV1 < 50% of predicted
- Oxygen saturation < 90% at rest during the day
- Poor compliance
- Patients with single chamber pacemaker (or ICD)
- Current use of PAP therapy
- Patients using amiodarone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades. The occurrence of AF is associated with significantly increased mortality as well as morbidity of which cerebrovascular accidents is the most important. Unfortunately treatment options remain limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential for toxicity and adverse events are recognized. Recent year's catheter ablation of AF continues to gain acceptance for symptomatic treatment, but recurrence rate are high with need for continuous medication. Thus there is a need to better understand what causes development and triggers episodes of AF as well to introduce new treatment options. Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore gained interest. Many patients with AF have chronic sleep apnea, and in the present study the investigators want to explore the interaction between SA and AF. The hypothesis of the present study is that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis the investigators will implant a Reveal device that continuously records the hearts rhythm of 100 patients with paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be examined, and the patients will then be randomized to treatment of SA or not and the influence on total AF burden recorded both before and after ablation.
Read the detailed description
For the present project the investigators have established a research team from 2 different university hospitals. This team, including high ranked, internationally renowned scientist from both clinical and basic sciences, will make a framework for PhD candidates and will ensure the patient cohort. Patients with paroxysmal AF and SA will be examined with an extensive diagnostic battery including advanced cardiac imaging tools allowing a proper description of the heart. Then a Reveal that continuously monitor the rhythm of the heart will be inserted, allowing the influence of SA, physical activity, inflammatory parameters, and other external variables on total AF burden to be examined. The patients will then be randomized to treatment of SA with a CPAP or not, and the AF burden recorded 6 months before ablation and 6 months after.
The present investigations carried out, are expected to results in better understanding of the interaction between AF and SA and may lay the scientific basis for better diagnostic and therapeutic approaches for patients with AF. In addition, given the advantage of continuous Reveal® recording of the patient's heart rhythm, the present study will examine possible triggers of AF such as activity level and inflammatory substances, and examine the role of structural abnormalities in the heart as assessed by echocardiography for the triggering of AF episodes. An overall aim is therefore a better phenotyping of the patient which could aid in a more person-specific treatment approach, with direct consequences both for the individual patient and for the society.
- Being tested
- PAP (CPAP or ASV)
- Keywords
- Atrial fibrillation, CPAP, Sleep apnea, Sleep disordered breathing
- Medical subject headings
- Sleep Apnea Syndromes, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP (CPAP or ASV)Device
Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
| Study group | Role | What they receive |
|---|---|---|
| PAP-therapy (CPAP or ASV) | Active comparator | Patients are randomized to either intervention Group: Positive airway pressure therapy (PAP-therapy) or Control. Patients in the intervention arm will be treated with PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV). Receives: Device: PAP (CPAP or ASV) |
| Control group | No intervention | No sleep apnea treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AF Burden
Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the five month intervention period.
Measured: Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.
Secondary outcomes (17)
Change in AF Burden
Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last month of the intervention period.
Measured: Baseline to the last month of intervention period
Change in AF Burden
Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last five months of the intervention period (the whole intervention period).
Measured: Comparing Baseline to the last five months of the intervention period
Number of Participants With More Than 25% Reduction in AF Burden
Difference between PAP treatment and usual care in the proportion of patients with at least 25% reduction of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the intervention period.
Measured: Baseline to last three months of the intervention
Change of Recurrence Rate After Ablation, as Measured by Loop Recorder
Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.
Measured: 12 months
Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)
Change in AF symptoms between CPAP treatment and usual care. The questionnaire quantifies three domains of AF: event frequency (score 1-10), duration (score 1-10), and global episode severity (score 1-10). The total AF burden is calculated from the modified sum of the frequency, duration, and severity of AF (score 3-30, with higher scores indicating greater AF burden ). In addition, the AFSS assesses a symptom score based on seven items asking how bothered patients are by specified symptoms (score 0-35). Global well-being is a visual analogue scale ranging from 1 to 10 (10 indicating the best possible life).
Measured: 6 months, 12 months and 18 months
Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Difference between CPAP and usual care in QoL as assessed by SF36, Version 1.2. Item scores are transformed into the Physical and Mental Component Summary scores (PCS and MCS). Scores range from 0 to 100, with higher scores indicating a better health state.
Measured: Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported.
Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score
Difference between PAP treatment and usual care in Change in daytime sleepiness as measured using the Epworth Sleepiness Scale (ESS) score, with scores ranging from 0 to 24 (most sleepy)
Measured: 6 months, 12 months and 18 months. Baseline and 6 months reported
Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.
Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Berlin Questionnaire. Positive scores in two or more categories suggest a high risk of OSA.
Measured: 6 months, 12 months and 18 months
Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Functional Outcomes of Sleep Questionnaire (FOSQ). Score range is 5-20 Points, with higher scores indicating better functional status.
Measured: 6 months, 12 months and 18 months. Baseline and 6 months reported.
Change in Symptoms of Sleep Apnea Measured by the STOP-Bang
Change in sleep quality and symptoms of obstructive sleep apnea as measured using the STOP-Bang Questionnaire. Score between 0-8. A score of ≥3 suggest risk for OSA.
Measured: 6 months, 12 months and 18 months
Change in CRP
Difference between PAP treatment and usual care in change of CRP
Measured: 6 months, 12 months and 18 months. Baseline and 6 months reported.
Change in Left Ventricular Ejection Fraction
Difference between PAP treatment and usual care in change of left ventricular ejection fraction as assessed by ecco
Measured: 6 months, 12 months and 18 months. Baseline and 6 months reported.
Change in the Cardiac Marker NT-proBNP.
Difference between PAP treatment and usual care in change of Cardiac marker of NT-proBNP.
Measured: 6 months, 12 months. Baseline and 6 months reported.
Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.
Examine the effect of SA treatment on gene Expression of white blood cells. Is paroxysmal AF Associated with specific gene Expression patterns? Examine the influence of SA treatment on the pattern of gene Expression and if this is related to reduction of atrial fibrillation burden
Measured: 6 months and 12 months
Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording
Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording
Measured: 6 months and 12 months
Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
Change in body composition (BMI) as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
Measured: Baseline to follow up 6 months
Lung Function Test as Assessed by Spirometry
Lung function test as assessed by spirometry
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start21 Jan 2016
- Primary completion1 Jul 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Gullestad, Oslo University Hospital
- Investigators
- Lars Gullestad, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727192
- Sponsor's protocol ID
- Gullestad
- Status last verified
- May 2021
- First submitted
- 29 Mar 2016
- Last updated
- 22 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ueland T, Traaen GM, Hunt TE, Aakeroy L, Overland B, Bendz C, Michelsen AE, Steinshamn S, Anfinsen OG, Aukrust P, Broch K, Akre H, Loennechen JP, Gullestad L. High levels of the adipokines leptin and metrnl in patients with paroxysmal atrial fibrillation and obstructive sleep apnea are not associated with the severity of sleep apnea or the burden of atrial fibrillation. Sleep Med. 2025 Dec;136:106862. doi: 10.1016/j.sleep.2025.106862. Epub 2025 Oct 16.
PubMed 41110405Traaen GM, Aakeroy L, Hunt TE, Overland B, Bendz C, Sande LO, Aakhus S, Fagerland MW, Steinshamn S, Anfinsen OG, Massey RJ, Broch K, Ueland T, Akre H, Loennechen JP, Gullestad L. Effect of Continuous Positive Airway Pressure on Arrhythmia in Atrial Fibrillation and Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):573-582. doi: 10.1164/rccm.202011-4133OC.
PubMed 33938787Traaen GM, Aakeroy L, Hunt TE, Overland B, Lyseggen E, Aukrust P, Ueland T, Helle-Valle T, Steinshamn S, Edvardsen T, Khiabani Zare H, Aakhus S, Akre H, Anfinsen OG, Loennechen JP, Gullestad L. Treatment of sleep apnea in patients with paroxysmal atrial fibrillation: design and rationale of a randomized controlled trial. Scand Cardiovasc J. 2018 Dec;52(6):372-377. doi: 10.1080/14017431.2019.1567933. Epub 2019 Feb 5.
PubMed 30638392
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02727192
- Acronym / sponsor ID
- Gullestad
- Keywords
- Atrial fibrillation, CPAP, Sleep apnea, Sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Health Association, Medtronic, ResMed
- Study start
- 21 Jan 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades. The occurrence of AF is associated with significantly increased mortality as well as morbidity of which cerebrovascular accidents is the most important. Unfortunately treatment options remain limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential for toxicity and adverse events are recognized. Recent year's catheter ablation of AF continues to gain acceptance for symptomatic treatment, but recurrence rate are high with need for continuous medication. Thus there is a need to better understand what causes development and triggers episodes of AF as well to introduce new treatment options. Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore gained interest. Many patients with AF have chronic sleep apnea, and in the present study the investigators want to explore the interaction between SA and AF. The hypothesis of the present study is that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis the investigators will implant a Reveal device that continuously records the hearts rhythm of 100 patients with paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be examined, and the patients will then be randomized to treatment of SA or not and the influence on total AF burden recorded both before and after ablation.
Detailed description
For the present project the investigators have established a research team from 2 different university hospitals. This team, including high ranked, internationally renowned scientist from both clinical and basic sciences, will make a framework for PhD candidates and will ensure the patient cohort. Patients with paroxysmal AF and SA will be examined with an extensive diagnostic battery including advanced cardiac imaging tools allowing a proper description of the heart. Then a Reveal that continuously monitor the rhythm of the heart will be inserted, allowing the influence of SA, physical activity, inflammatory parameters, and other external variables on total AF burden to be examined. The patients will then be randomized to treatment of SA with a CPAP or not, and the AF burden recorded 6 months before ablation and 6 months after.
The present investigations carried out, are expected to results in better understanding of the interaction between AF and SA and may lay the scientific basis for better diagnostic and therapeutic approaches for patients with AF. In addition, given the advantage of continuous Reveal® recording of the patient's heart rhythm, the present study will examine possible triggers of AF such as activity level and inflammatory substances, and examine the role of structural abnormalities in the heart as assessed by echocardiography for the triggering of AF episodes. An overall aim is therefore a better phenotyping of the patient which could aid in a more person-specific treatment approach, with direct consequences both for the individual patient and for the society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAP-therapy (CPAP or ASV) | Active comparator | Device: PAP (CPAP or ASV)Patients are randomized to either intervention Group: Positive airway pressure therapy (PAP-therapy) or Control. Patients in the intervention arm will be treated with PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV). |
| Control group | No intervention | –No sleep apnea treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- Male or female
- Patients with paroxysmal AF scheduled for first or second catheter ablation
- Moderate-to-severe SA defined as an AHI ≥15/h (OSA and/or CSA)
- Signed informed consent
Key exclusion criteria (13 listed)
- Unstable patients
- Patients with left ventricular ejection fraction (LV-EF) < 45%
- Unstable coronary artery disease, myocardial infarction or PCI within 3 months prior to the study
- Bypass surgery within 6 months prior to the study
- Patients with TIA or stroke within the previous 3 months
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 |
|---|---|---|
| PAP (CPAP or ASV)Patients will be randomized to treatment of Sleep Apnea with a CPAP or control | Device | PAP-therapy (CPAP or ASV) |
Primary outcome
Change in AF Burden
Time frame: Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.
Difference between PAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the five month intervention period.
17 secondary outcomes
Change in AF Burden
Time frame: Baseline to the last month of intervention period
Change in AF Burden
Time frame: Comparing Baseline to the last five months of the intervention period
Number of Participants With More Than 25% Reduction in AF Burden
Time frame: Baseline to last three months of the intervention
Change of Recurrence Rate After Ablation, as Measured by Loop Recorder
Time frame: 12 months
Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)
Time frame: 6 months, 12 months and 18 months
Change in Quality of Life (QoL) as Assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)
Time frame: Assessed at baseline, 6 months, 12 months and 18 months, baseline and 6 months reported.
Change in Sleep Quality and Symptoms of Sleep Apnea: Epworth Sleepiness Scale (ESS) Score
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported
Change in Symptoms of Obstructive Sleep Apnea Assessed by the Berlin Questionnaire.
Time frame: 6 months, 12 months and 18 months
Change in Symptoms of Sleep Apnea Using the Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
Change in Symptoms of Sleep Apnea Measured by the STOP-Bang
Time frame: 6 months, 12 months and 18 months
Change in CRP
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
Change in Left Ventricular Ejection Fraction
Time frame: 6 months, 12 months and 18 months. Baseline and 6 months reported.
Change in the Cardiac Marker NT-proBNP.
Time frame: 6 months, 12 months. Baseline and 6 months reported.
Examine the Effect of SA Treatment on Gene Expression of White Blood Cells.
Time frame: 6 months and 12 months
Examine if Onset of Paroxysmal AF is Associated With Specific Activity Patterns, as Assessed by Garmin Vivofit2/3, Activity Recording
Time frame: 6 months and 12 months
Change in Body Composition as Assessed by Bioelectric Impedance Analysis (BIA) (Tanita)
Time frame: Baseline to follow up 6 months
Lung Function Test as Assessed by Spirometry
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41110405Ueland T, Traaen GM, Hunt TE, Aakeroy L, Overland B, Bendz C, Michelsen AE, Steinshamn S, Anfinsen OG, Aukrust P, Broch K, Akre H, Loennechen JP, Gullestad L. High levels of the adipokines leptin and metrnl in patients with paroxysmal atrial fibrillation and obstructive sleep apnea are not associated with the severity of sleep apnea or the burden of atrial fibrillation. Sleep Med. 2025 Dec;136:106862. doi: 10.1016/j.sleep.2025.106862. Epub 2025 Oct 16.
- Derived from this study: PubMed 33938787Traaen GM, Aakeroy L, Hunt TE, Overland B, Bendz C, Sande LO, Aakhus S, Fagerland MW, Steinshamn S, Anfinsen OG, Massey RJ, Broch K, Ueland T, Akre H, Loennechen JP, Gullestad L. Effect of Continuous Positive Airway Pressure on Arrhythmia in Atrial Fibrillation and Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):573-582. doi: 10.1164/rccm.202011-4133OC.
- Derived from this study: PubMed 30638392Traaen GM, Aakeroy L, Hunt TE, Overland B, Lyseggen E, Aukrust P, Ueland T, Helle-Valle T, Steinshamn S, Edvardsen T, Khiabani Zare H, Aakhus S, Akre H, Anfinsen OG, Loennechen JP, Gullestad L. Treatment of sleep apnea in patients with paroxysmal atrial fibrillation: design and rationale of a randomized controlled trial. Scand Cardiovasc J. 2018 Dec;52(6):372-377. doi: 10.1080/14017431.2019.1567933. Epub 2019 Feb 5.
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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.
Lars Gullestad, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAP (CPAP or ASV) in people with Sleep Disordered Breathing and Sleep Apnea, run by Oslo University Hospital at 1 site in Norway.
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 13 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in AF Burden (time frame: Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.). 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 NCT02727192, which also lists 3 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 22 Jun 2021.