Patients With Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
The Effect of Simulated Obstructive Apnoea and Hypopnoea on Heart Rhythm in Patients With Paroxysmal Atrial Fibrillation
| Verified date | December 2013 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Division of Pneumology | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of subjects with premature myocardial contractions and/or atrial fibrillation | 20 seconds | No | |
| Secondary | ECG-derived myocardial de- and repolarization times | 20 seconds | No |