Non-invasive Differentiation of Supraventricular Tachyarrhythmia

Atrial Fibrillation Clinical Trial

— NIDSA  

Official title:

Non-invasive Differentiation of Supraventricular Tachyarrhythmias by Questionnaire and High-resolution ECG in the Context of Ablation Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061120
• Other study ID #: CTCA 21-083
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 30, 2026

Study information

• Verified date: September 2023
• Source: RWTH Aachen University
• Contact: Matthias D Zink, MD
• Phone: 00492418035113
• Email: mzink[@]ukaachen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Questionnaire for supraventricular tachycardia: About history and targeted diagnosis of supraventricular tachycardia 2. Extended Signal-averaged ECG for detailed P-Wave analysis and to calculate a virtual atrial electrocardiogram (ECG)

Description:

1. Questionnaire Patient questionnaires on supraventricular tachycardia including atrial fibrillation often refer to the symptoms of the cardiac arrhythmia and the resulting limitations in everyday life. The evaluation of these questionnaires only allows a rough differentiation between the various cardiac arrhythmias. Nevertheless, it is known that supraventricular tachycardias are influenced by the sympathetic and parasympathetic nervous system. For example, tachyarrhythmias can begin or be terminated with a reentry circuit through the atrioventricular (AV) node by Valsalva manoeuvres or some other change in tone of the nervus vagus. For atrioventricular reentrytachycardia (AVNRT) in particular, an increased probability of occurrence in poststress phases has been described, as well as an association with certain behaviours such as positional changes, but also alcohol and drug consumption. To date, there is no systematic questionnaire on the specific triggering and terminating components. All patients referred for ablation of a supraventricular arrhythmia and potentially included in this project will receive a detailed history of the triggering and terminating factors using a structured questionnaire, as well as two validated supraventricular tachycardia questionnaires (5Q-3L and ASTA) to classify the results of our questionnaire. 2. Extended ECG A high-resolution and signal-averaged ECG is recorded with a significantly higher resolution than a 12-lead ECG over a period of several minutes. Additional electrode positions are also used in the vicinity of the examined structure, e.g. the left atrium. The signal from several recorded heartbeats is then averaged. This preserves repetitive smallest atrial excitation patterns and changes. In this way, it is possible to find indications of cardiac arrhythmias like atrial fibrillation in the signal-averaged ECG, which were not detectable in a 12-lead ECG.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1250
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
• majority

Exclusion Criteria:

• Unstable patient with need for intensive medical care
• Lack of language skills or limited cognitive abilities that prevent a differentiated anamnesis and information.

Exclusion criteria for study section Questionnaire:

• Competing clinically present arrhythmias, including relevant supra- and ventricular extrasystole (>5%/die).

Exclusion criteria for study section Extended high-resolution ECG:

• Previous electrophysiological ablation at the same site for atrial fibrillation.
• Relevant supra- and ventricular extrasystole (>5%/die).
• Other clinically present arrhythmias are not excluded if they can be sequentially triggered and ablated (e.g. atrial fibrillation and atrial flutter). Since separate detection is possible with the high-resolution ECG.
• Implanted active electrical device (e.g. pacemaker, defibrillator, deep brain pacemaker)
• Allergy to measuring electrodes

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Supraventricular Arrhythmia
• Tachycardia

Intervention

Device:
• Recording of an extended high-resolution ECG
Recording of an extended high-resolution ECG

Locations

Country	Name	City	State
Germany	RWTH Aachen University	Aachen	Northrhine-Westphalia

Sponsors (4)

Lead Sponsor	Collaborator
RWTH Aachen University	Chair of Medical Information Technology Helmholtz Institute, RWTH Aachen University, Department of Internal Medicine I - Cardiology, KKS -Kardiologisches Klinisches Studienzentrum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Triggers of supraventricular arrhythmia	Anamnestic and ECG measured triggers of supra ventricular arrhythmia	2 years
Secondary	P-Wave duration	Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters	2 years
Secondary	P-Wave amplitude	Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters	2 years
Secondary	P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak)	Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters	2 years
Secondary	Signal-averaged P-Wave sample entropy	Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters	2 years
Secondary	Signal-averaged P-Wave shannon entropy	Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters	2 years
Secondary	Signal-averaged P-Wave complexity	Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters	2 years
Secondary	Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology	By recording of unfiltered high-resolution ECG and calculation of a signal-averaged P-Wave and other post-processing techniques a better visualization of ongoing arrhythmia shall be achieved	2 years