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NCT Number: NCT06061120

Non-invasive Differentiation of Supraventricular Tachyarrhythmia

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recording of an extended high-resolution ECG

Device

Recording of an extended high-resolution ECG

Primary outcomes

  1. Triggers of supraventricular arrhythmia

    Time frame: 2 years

    Anamnestic and ECG measured triggers of supra ventricular arrhythmia

Secondary outcomes

  1. P-Wave duration

    Time frame: 2 years

    Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

  2. P-Wave amplitude

    Time frame: 2 years

    Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

  3. P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak)

    Time frame: 2 years

    Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

  4. Signal-averaged P-Wave sample entropy

    Time frame: 2 years

    Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

  5. Signal-averaged P-Wave shannon entropy

    Time frame: 2 years

    Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

  6. Signal-averaged P-Wave complexity

    Time frame: 2 years

    Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters

  7. Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Matthias D Zink, MD

CONTACT

[email protected]

00492418035113

Michael Gramlich

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • Department of Internal Medicine I - Cardiology
  • KKS -Kardiologisches Klinisches Studienzentrum

Registry information

Official study title

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

Acronym: NIDSA

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Sep 29, 2023
Registry last updated
Sep 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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