NIDSA: Non-invasive Differentiation of Supraventricular Tachyarrhythmia

Sponsor
RWTH Aachen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06061120
Collaborator
Department of Internal Medicine I - Cardiology (Other), KKS -Kardiologisches Klinisches Studienzentrum (Other), Chair of Medical Information Technology Helmholtz Institute, RWTH Aachen University (Other)
1,250
1
60.9
20.5

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Device: Recording of an extended high-resolution 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-invasive Differentiation of Supraventricular Tachyarrhythmias by Questionnaire and High-resolution ECG in the Context of Ablation Treatment
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Questionnaire - Supraventricular arrhythmia

Questionnaire about triggers and stops of supra ventricular arrhythmia

Extended ECG - Effect of electrophysiological ablation

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

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

Extended ECG - Virtual atrial Electrocardiogram

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

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

Outcome Measures

Primary Outcome Measures

  1. Triggers of supraventricular arrhythmia [2 years]

    Anamnestic and ECG measured triggers of supra ventricular arrhythmia

Secondary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 RWTH Aachen University Aachen Northrhine-Westphalia Germany 52074

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Matthias D Zink, MD, RWTH Aachen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matthias Zink, Dr. med., RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT06061120
Other Study ID Numbers:
  • CTCA 21-083
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Matthias Zink, Dr. med., RWTH Aachen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023