- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06061120
Non-invasive Differentiation of Supraventricular Tachyarrhythmia (NIDSA)
Non-invasive Differentiation of Supraventricular Tachyarrhythmias by Questionnaire and High-resolution ECG in the Context of Ablation Treatment
- Questionnaire for supraventricular tachycardia: About history and targeted diagnosis of supraventricular tachycardia
- Extended Signal-averaged ECG for detailed P-Wave analysis and to calculate a virtual atrial electrocardiogram (ECG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matthias D Zink, MD
- Phone Number: 00492418035113
- Email: mzink@ukaachen.de
Study Contact Backup
- Name: Michael Gramlich
- Email: mgramlich@ukaachen.de
Study Locations
-
-
Northrhine-Westphalia
-
Aachen, Northrhine-Westphalia, Germany, 52074
- Recruiting
- RWTH Aachen University
-
Contact:
- Matthias D Zink
- Phone Number: 02418035227
- Email: mzink@ukaachen.de
-
Contact:
- Zakiya Coenen-Basmadjie
- Phone Number: 02418035227
- Email: zcoenen@ukaachen.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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
|
Recording of an extended high-resolution ECG
|
Extended ECG - Virtual atrial Electrocardiogram
Improve visualisation of atrial arrhythmia by means of extended signal-averaged ECGs
|
Recording of an extended high-resolution ECG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Triggers of supraventricular arrhythmia
Time Frame: 2 years
|
Anamnestic and ECG measured triggers of supra ventricular arrhythmia
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
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
|
2 years
|
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
|
2 years
|
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
|
2 years
|
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
|
2 years
|
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
|
2 years
|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthias D Zink, MD, RWTH Aachen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTCA 21-083
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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