Enhanced Diagnostics for Early Detection of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— DETECT-AF  

Official title:

Enhanced Diagnostics for Early Detection of Atrial Fibrillation - DETECT AF Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270112
• Other study ID #: EKNZ:2014-080
• Status: Completed
• Phase: N/A
• First received: October 3, 2014
• Last updated: December 12, 2017
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• paroxysmal atrial fibrillation in sinus rhythm at presentation

Exclusion Criteria:

• acute cerebral trauma

• antiarrhythmic medication

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• ECG
Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beat to beat variation of the electrical activation vector of the atrium	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.	Once during the exam (baseline) - No further follow up planned
Secondary	Averaged slope of pressure-curve	Test if the steepness of the slope of the pressure curve recorded with the iPhone differs between the two Groups.	Once during exam (5min, baseline) - No further follow up planned
Secondary	Averaged slope of pressure-curve	Test if the steepness of the slope of the pressure curve recorded with the iPhone correlates with cardiovascular risk factors.	Once during exam (5min, baseline) - No further follow up planned
Secondary	Heart rate variability	Test if heart rate variability recorded with the iPhone differs between the two Groups.	Once during exam (5min, baseline) - No further follow up planned