Enhanced Diagnostics for Early Detection of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02270112
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Paroxysmal atrial fibrillation can only be diagnosed during episodes when the arrhythmia is present.

The investigators hypothesize that the activation of the atrial myocardium resulting in the p-wave of the ecg should display abnormalities in diseased atria which are vulnerable for AF.

Detailed Description

In the first part of this trial different diagnostic techniques to detect arrythmogenic substrates of atrial fibrillation will be tested. If suitable parameters can be identified, a follow up trial to identify patients at risk for AF will be conducted before a stroke happens.

Parameters tested are

1. Electrophysiological differences between patients with paroxysmal AF and no history of AF

2. "Vascular Stiffness" detected by an iPhone app

All patients will undergo a cardiogoniometrie and a pulse wave analysis with an iPhone. Each exam takes 5 minutes.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-10-03
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-12
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

• paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion Criteria

• acute cerebral trauma
• antiarrhythmic medication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beat to beat variation of the electrical activation vector of the atrium	Once during the exam (baseline) - No further follow up planned	Test if the beat to beat Variation of the electrical activation of the atrium differentiates between the group of patients with paroxysmal AF and no AF in history.

Secondary Outcome Measures

Name	Time	Method
Averaged slope of pressure-curve	Once during exam (5min, baseline) - No further follow up planned	Test if the steepness of the slope of the pressure curve recorded with the iPhone correlates with cardiovascular risk factors.
Heart rate variability	Once during exam (5min, baseline) - No further follow up planned	Test if heart rate variability recorded with the iPhone differs between the two Groups.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, BS, Switzerland