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Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02269774
Recruitment Status : Terminated (Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.)
First Posted : October 21, 2014
Last Update Posted : October 25, 2016
Sponsor:
Information provided by (Responsible Party):
Malcolm Kohler, University of Zurich

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Sleep Apnea, Obstructive Atrial Premature Complexes Procedure: Standard pulmonary vein isolation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
Study Start Date : September 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: Standard pulmonary vein isolation
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    (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.


Secondary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269774


Locations
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Switzerland
University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Malcolm Kohler, MD, Prof University of Zurich
More Information
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Responsible Party: Malcolm Kohler, Malcolm Kohler, Prof MD, University of Zurich
ClinicalTrials.gov Identifier: NCT02269774    
Other Study ID Numbers: KEK-ZH-Nr. 2014-0203
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 25, 2016
Last Verified: October 2016
Keywords provided by Malcolm Kohler, University of Zurich:
Atrial Fibrillation
Obstructive Sleep Apnea
Atrial Premature Complexes
Pulmonary Vein Isolation
Mueller Manoeuvre
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Premature Birth
Atrial Fibrillation
Atrial Premature Complexes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Cardiac Conduction System Disease