- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02269774
Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
October 24, 2016 updated by: Malcolm Kohler, University of Zurich
Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
There is accumulating evidence for obstructive sleep apnea (OSA) as an independent risk factor for paroxysmal atrial fibrillation and for high recurrence rates of atrial fibrillation after ablation therapy.
We have previously shown that simulated OSA triggers premature atrial beats (PABs) by acute changes in intra-thoracic pressure.
Most episodes of atrial fibrillation are initiated by PABs.
However, the origin of PABs induced by intra-thoracic pressure swings is unknown.
This study investigates the origin of premature atrial beats induced by intra-thoracic pressure changes that simulate obstructive sleep apnea in patients with atrial fibrillation.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Canton of Zurich
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Zurich, Canton of Zurich, Switzerland, 8091
- University Hospital of Zürich
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
- Scheduled for circumferential pulmonary venous isolation treatment
- 18 to 75 years of age
- Signed informed consent
Exclusion Criteria:
- Treated with class III anti-arrhythmic agents (at the moment of pulmonary venous isolation)
- Treated for obstructive sleep apnea
- Previous catheter ablation in the pulmonary veins or left atrium
- Severe structural heart disease
- Mental or physical disability precluding informed consent or compliance with the protocol
- Enrolled in another study that would confound the results of this trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Pulmonary vein isolation
Intra-thoracic pressure swings induced by breathing manoeuvres during standard catheter-ablation procedure.
Catheter-based electrical mapping and pressure in the left atrium and pulmonary veins during standard catheter-ablation procedure.
Only patients with an apnea-hypopnea index > 5/h and documented premature atrial beats during the Mueller manoeuvre will be eligible for the catheter-based electrical mapping.
Follow-up after 1 year for atrial fibrillation recurrence.
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The MM will be carried out during a elective standard pulmonary vein isolation procedure.
The MM will be performed using an occluded mouthpiece with a small air leak to prevent complete closure of the glottis during inspiration and thus assure negative pressure throughout the entire airway.
After expiration, inspiration with a target negative intrathoracic pressure of -40mmHg will be carried out against the mouthpiece.
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No Intervention: No intevention
Intra-thoracic pressure swings induced by breathing manoeuvres during ECG-monitoring.
Only patients with an apnea-hypopnea index < 5/h and no premature atrial beats during the Mueller manoeuvre will be assigned to the no intervention arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroanatomical origin of premature atrial beats
Time Frame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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(Loop-)Catheter-based origin detection in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre (MM).
Origins will be quantitatively marked at a left atrial map.
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Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes
Time Frame: Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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Catheter-based left atrial pressure measurement in patients with apnea-hypopnea index > 5/h in home sleep study and documented premature atrial beats during three time points: baseline (normal breathing), inspiration through a threshold load device, and the Mueller Manoeuvre.
Changes in left atrial pressure will be recorded in cmH2O.
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Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Malcolm Kohler, MD, Prof, University of Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
October 14, 2014
First Submitted That Met QC Criteria
October 20, 2014
First Posted (Estimate)
October 21, 2014
Study Record Updates
Last Update Posted (Estimate)
October 25, 2016
Last Update Submitted That Met QC Criteria
October 24, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Cardiac Complexes, Premature
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Atrial Fibrillation
- Premature Birth
- Atrial Premature Complexes
Other Study ID Numbers
- KEK-ZH-Nr. 2014-0203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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