Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

Sponsor

University of Zurich (Other)

Overall Status

Terminated

CT.gov ID

NCT02269774

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Sep 1, 2014

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

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.	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.

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.

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

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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