The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01796080
First received: February 18, 2013
Last updated: December 20, 2013
Last verified: December 2013

February 18, 2013
December 20, 2013
October 2012
December 2013   (final data collection date for primary outcome measure)
Number of subjects with premature myocardial contractions and/or atrial fibrillation [ Time Frame: 20 seconds ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01796080 on ClinicalTrials.gov Archive Site
ECG-derived myocardial de- and repolarization times [ Time Frame: 20 seconds ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation

In this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Patients With Paroxysmal Atrial Fibrillation
  • Other: Mueller manoeuvre
  • Other: Inspiratory threshold
  • Other: Expiratory apnoea
  • Other: Steady state normal breathing
  • Active Comparator: Mueller manoeuvre
    Mueller manoeuvre lasting for 20 seconds
    Intervention: Other: Mueller manoeuvre
  • Active Comparator: Inspiratory threshold
    One continuous inspiration through an inspiratory threshold load for 20 seconds
    Intervention: Other: Inspiratory threshold
  • Active Comparator: Expiratory apnoea
    Expiratory apnoea (without respiratory effort) lasting for 20 seconds
    Intervention: Other: Expiratory apnoea
  • Sham Comparator: Steady state normal breathing
    Steady state normal breathing for 20 seconds
    Intervention: Other: Steady state normal breathing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Age 18-75 years
  • History of ECG-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm
  • Informed consent

Exclusion criteria:

  • Mental or physical disability precluding informed consent or compliance with the protocol
  • Amiodarone or Dronedarone medication
  • Previous radiofrequency ablation for atrial fibrillation
  • Severe structural heart disease
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01796080
PAF_V1.1 (05.07.2012)
No
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Malcolm Kohler, Prof MD University Hospital Zurich, Division of Pneumology
University of Zurich
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP