Non-invasive Differentiation of Supraventricular Tachyarrhythmia

NCT ID: NCT06061120

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2026-09-30

Brief 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)

Detailed 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.

Conditions

Supraventricular Arrhythmia; Atrial Fibrillation

Keywords

Electrocardiogram; Signal-averaged P-Wave; Questionnaire; Supraventricular Arrhythmia; Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Questionnaire - Supraventricular arrhythmia

Questionnaire about triggers and stops of supra ventricular arrhythmia

No interventions assigned to this group

Extended ECG - Effect of electrophysiological ablation

Extended signal-averaged ECGs in patients with ablation of supra ventricular ablation

Recording of an extended high-resolution ECG

Intervention Type: DEVICE

Recording of an extended high-resolution ECG

Extended ECG - Virtual atrial Electrocardiogram

Improve visualisation of atrial arrhythmia by means of extended signal-averaged ECGs

Recording of an extended high-resolution ECG

Intervention Type: DEVICE

Recording of an extended high-resolution ECG

Interventions

Recording of an extended high-resolution ECG

Recording of an extended high-resolution ECG

Intervention Type: DEVICE

Eligibility Criteria

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.

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Internal Medicine I - Cardiology

UNKNOWN

Sponsor Role: collaborator

KKS -Kardiologisches Klinisches Studienzentrum

UNKNOWN

Sponsor Role: collaborator

Chair of Medical Information Technology Helmholtz Institute, RWTH Aachen University

UNKNOWN

Sponsor Role: collaborator

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Matthias Zink

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias D Zink, MD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University

Locations

RWTH Aachen University

Aachen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Matthias D Zink, MD

Role: CONTACT

Phone: 00492418035113

Email: mzink@ukaachen.de

Michael Gramlich

Role: CONTACT

Email: mgramlich@ukaachen.de

Facility Contacts

Matthias D Zink

Role: primary

Zakiya Coenen-Basmadjie

Role: backup

Other Identifiers

CTCA 21-083

Identifier Type: -

Identifier Source: org_study_id