Health TrialsbyHealthPanel

Non-invasive Differentiation of Supraventricular Tachyarrhythmia

ConditionsSupraventricular ArrhythmiaAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRWTH Aachen University

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

majority

Disqualifiers

Unstable patient with need for intensive medical care

Lack of language skills or limited cognitive abilities that prevent a differentiated anamnesis and information.

Previous electrophysiological ablation at the same site for atrial fibrillation.

Relevant supra- and ventricular extrasystole (>5%/die).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Recording of an extended high-resolution ECG

    Device

    Recording of an extended high-resolution ECG

Treatment groups

1,250 Participants
are divided into 3 treatment groups
Group A: Questionnaire - Supraventricular arrhythmia0 interventions
Group B: Extended ECG - Effect of electrophysiological ablation1 intervention
Group C: Extended ECG - Virtual atrial Electrocardiogram1 intervention

Trial outcomes

Primary outcomes

1

Triggers of supraventricular arrhythmia

Anamnestic and ECG measured triggers of supra ventricular arrhythmia

Time frame
2 years

Secondary outcomes

1

P-Wave duration

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

Time frame
2 years
2

P-Wave amplitude

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

Time frame
2 years
3

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

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

Time frame
2 years
4

Signal-averaged P-Wave sample entropy

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

Time frame
2 years

Other outcomes

Sponsors and contacts

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RWTH Aachen University

Lead sponsor

Department of Internal Medicine I - Cardiology

Collaborator

KKS -Kardiologisches Klinisches Studienzentrum

Collaborator

Source ClinicalTrials.gov
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