Non-invasive Differentiation of Supraventricular Tachyarrhythmia
- Conditions
- Supraventricular ArrhythmiaAtrial Fibrillation
- Interventions
- Device: Recording of an extended high-resolution ECG
- Registration Number
- NCT06061120
- Lead Sponsor
- RWTH Aachen University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
- majority
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Extended ECG - Virtual atrial Electrocardiogram Recording of an extended high-resolution ECG Improve visualisation of atrial arrhythmia by means of extended signal-averaged ECGs Extended ECG - Effect of electrophysiological ablation Recording of an extended high-resolution ECG Extended signal-averaged ECGs in patients with ablation of supra ventricular ablation
- Primary Outcome Measures
Name Time Method Triggers of supraventricular arrhythmia 2 years Anamnestic and ECG measured triggers of supra ventricular arrhythmia
- Secondary Outcome Measures
Name Time Method P-Wave amplitude 2 years Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Signal-averaged P-Wave complexity 2 years Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
P-Wave duration 2 years Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Signal-averaged P-Wave sample entropy 2 years Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Signal-averaged P-Wave shannon entropy 2 years Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology 2 years 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
P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak) 2 years Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Trial Locations
- Locations (1)
RWTH Aachen University
🇩🇪Aachen, Northrhine-Westphalia, Germany