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Non-invasive Differentiation of Supraventricular Tachyarrhythmia

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06061120
Acronym
NIDSA
Enrollment
1250
Registered
2023-09-29
Start date
2021-09-01
Completion date
2026-09-30
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Supraventricular Arrhythmia

Keywords

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

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.

Interventions

DEVICERecording of an extended high-resolution ECG

Recording of an extended high-resolution ECG

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Triggers of supraventricular arrhythmia2 yearsAnamnestic and ECG measured triggers of supra ventricular arrhythmia

Secondary

MeasureTime frameDescription
P-Wave amplitude2 yearsCharacteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak)2 yearsCharacteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Signal-averaged P-Wave sample entropy2 yearsCharacteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
P-Wave duration2 yearsCharacteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Signal-averaged P-Wave complexity2 yearsCharacteristics 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 morphology2 yearsBy 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
Signal-averaged P-Wave shannon entropy2 yearsCharacteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

Countries

Germany

Contacts

Primary ContactMatthias D Zink, MD
mzink@ukaachen.de00492418035113
Backup ContactMichael Gramlich
mgramlich@ukaachen.de

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026