Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea

NCT02269774 | Terminated

• 1 other identifier: KEK-ZH-Nr. 2014-0203
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Atrial Premature Complexes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

Pulmonary vein isolation

OTHER

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

No intevention

NO INTERVENTION

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.

Interventions

Standard pulmonary vein isolation PROCEDURE

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.

Pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
• Scheduled for circumferential pulmonary venous isolation treatment
• to 75 years of age
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Study Officials

• Malcolm Kohler, MD, Prof

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Malcolm Kohler, Prof MD

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 21, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

CH (1)