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Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02269774
Enrollment
2
Registered
2014-10-21
Start date
2014-09-30
Completion date
2016-01-31
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Atrial Premature Complexes, Sleep Apnea, Obstructive

Keywords

Atrial Fibrillation, Obstructive Sleep Apnea, Atrial Premature Complexes, Pulmonary Vein Isolation, Mueller Manoeuvre

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.

Interventions

PROCEDUREStandard 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.

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Electroanatomical origin of premature atrial beatsParticipants 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

MeasureTime frameDescription
Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changesParticipants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hoursCatheter-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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026