Non-invasive Differentiation of Supraventricular Tachyarrhythmia

NCT06061120 | Recruiting DMC

• 1 other identifier: CTCA 21-083
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Questionnaire for supraventricular tachycardia: About history and targeted diagnosis of supraventricular tachycardia
2. 2.Extended Signal-averaged ECG for detailed P-Wave analysis and to calculate a virtual atrial electrocardiogram (ECG)

Conditions

Supraventricular Arrhythmia; Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Triggers of supraventricular arrhythmia

  Anamnestic and ECG measured triggers of supra ventricular arrhythmia

  2 years

Secondary Outcomes (7)

• P-Wave duration

  2 years

• P-Wave amplitude

  2 years

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

  2 years

• Signal-averaged P-Wave sample entropy

  2 years

• Signal-averaged P-Wave shannon entropy

  2 years

Study Arms (3)

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

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

Interventions

Recording of an extended high-resolution ECG DEVICE

Recording of an extended high-resolution ECG

Extended ECG - Effect of electrophysiological ablation; Extended ECG - Virtual atrial Electrocardiogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cohort for study section Questionnaire: 1000 evaluable questionnaires are targeted. Every suitable potential respondent will be invited and interviewed during the data collection period. After 400 subjects in the questionnaire section, an interim evaluation will be carried out. Cohort for study section extended high-resolution ECG: In a feasibility study, signal-enhanced ECGs will be recorded in a subgroup of cohort before, during and after ablation with the aim of non-invasive ECG diagnostics. There are no published empirical values for this and 250 subjects will be notified. After 100 subjects in the high-resolution ECG section, an interim evaluation will be carried out.

You may qualify if:

• Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
• majority

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (1)

• Fantazi N, Hermans BJM, Zeemering S, Berbers J, Emrani M, Napp A, Marx N, Gramlich M, Schotten U, Zink MD. Acute effect of cryoballoon pulmonary vein isolation on the signal-averaged P-wave. Front Cardiovasc Med. 2026 Jan 20;12:1728939. doi: 10.3389/fcvm.2025.1728939. eCollection 2025.

  PMID: 41640583 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthias D Zink, MD

  RWTH Aachen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthias D Zink, MD

CONTACT

00492418035113; mzink@ukaachen.de

Michael Gramlich

CONTACT

mgramlich@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: September 29, 2023
• Study Start: September 1, 2021
• Primary Completion: September 30, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

DE (1)