Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

Not Applicable

Terminated

• Conditions: Atrial Premature Complexes; Atrial Fibrillation; Sleep Apnea, Obstructive
• Interventions: Procedure: Standard pulmonary vein isolation

• Registration Number: NCT02269774
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-21
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulmonary vein isolation	Standard 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.

Primary Outcome Measures

Name	Time	Method
Electroanatomical origin of premature atrial beats	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

Name	Time	Method
Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes	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.

Trial Locations

Locations (1)

University Hospital of Zurich; 🇨🇭 Zurich, Canton of Zurich, Switzerland