Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02269774
• Other study ID #: KEK-ZH-Nr. 2014-0203
• Status: Terminated
• Phase: N/A
• First received: October 14, 2014
• Last updated: October 24, 2016
• Start date: September 2014
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Apnea
• Atrial Fibrillation
• Atrial Premature Complexes
• Premature Birth
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Zurich	Zurich	Canton of Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes	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.	Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours	No