Back to resultsOrigin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
Primary Purpose
Atrial Fibrillation, Sleep Apnea, Obstructive, Atrial Premature Complexes
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Standard pulmonary vein isolation
Sponsored by
About this trial
This is an interventional basic science trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Obstructive Sleep Apnea, Atrial Premature Complexes, Pulmonary Vein Isolation, Mueller Manoeuvre
Eligibility Criteria
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
Sites / Locations
- University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Pulmonary vein isolation
No intevention
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02269774
First Posted
October 14, 2014
Last Updated
October 24, 2016
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT02269774
Brief Title
Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to the strict in- and exclusion criteria only few patients could be enrolled into the study.
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Sleep Apnea, Obstructive, Atrial Premature Complexes
Keywords
Atrial Fibrillation, Obstructive Sleep Apnea, Atrial Premature Complexes, Pulmonary Vein Isolation, Mueller Manoeuvre
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary vein isolation
Arm Type
Other
Arm Description
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.
Arm Title
No intevention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard pulmonary vein isolation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electroanatomical origin of premature atrial beats
Description
(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.
Time Frame
Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
Secondary Outcome Measure Information:
Title
Catheter-based pressure in the left atrium and pulmonary veins during intra-thoracic pressure changes
Description
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.
Time Frame
Participants will be followed for the duration of pulmonary vein isolation, an expected average of 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Kohler, MD, Prof
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
State/Province
Canton of Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea
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