Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.
Electroanatomic Origin of Premature Atrial Beats in Patients With Paroxysmal Atrial Fibrillation Induced by Intra-thoracic Pressure Swings Simulating Obstructive Sleep Apnea
Sponsor study identifier
interventional
2
1 country
1
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2014
Actual (reported)October 21, 2014
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)Electroanatomical origin of premature atrial beats
(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.
Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital of Zurich
Zurich, Canton of Zurich, 8091, Switzerland
Malcolm Kohler, MD, Prof
University of Zurich
2 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2014
First Posted
October 21, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
October 25, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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