Supraventricular ArrhythmiaNIDSANCT06061120
Non-invasive Differentiation of Supraventricular Tachyarrhythmia
An observational study of Supraventricular Arrhythmia and Atrial Fibrillation, run by RWTH Aachen University at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraventricular Arrhythmia, Atrial Fibrillation
- What is being tested?
- Recording of an extended high-resolution ECG
- Type of treatment
- Medical device
- How many people
- 1,250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2021to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
- majority
Who cannot join
- 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).
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Michael Gramlich contact
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University
Aachen, North Rhine-Westphalia, 52074
Matthias D Zink, 02418035227, mzink@ukaachen.de
Zakiya Coenen-Basmadjie, 02418035227, zcoenen@ukaachen.de
About this study
Official title: 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)
Read the 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.
- Conditions
- Supraventricular Arrhythmia, Atrial Fibrillation
- Being tested
- Recording of an extended high-resolution ECG
- Keywords
- Electrocardiogram, Signal-averaged P-Wave, Questionnaire, Supraventricular Arrhythmia, Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of an extended high-resolution ECGDevice
Recording of an extended high-resolution ECG
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Recording of an extended high-resolution ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triggers of supraventricular arrhythmia
Anamnestic and ECG measured triggers of supra ventricular arrhythmia
Measured: 2 years
Secondary outcomes (7)
P-Wave duration
Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Measured: 2 years
P-Wave amplitude
Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Signal-averaged P-Wave shannon entropy
Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Measured: 2 years
Signal-averaged P-Wave complexity
Characteristics and changes by ablation of atrial electrical activation will be analyzed by means of signal-averaged P-Wave parameters
Measured: 2 years
Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraventricular ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Internal Medicine I - Cardiology, KKS -Kardiologisches Klinisches Studienzentrum
- Responsible party
- Principal investigator, Matthias Zink, RWTH Aachen University
- Investigators
- Matthias D Zink, MD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061120
- Sponsor's protocol ID
- CTCA 21-083
- Acronym
- NIDSA
- Status last verified
- Sep 2023
- First submitted
- 25 Oct 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared on reasonable request after data is already published
Publications
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.
PubMed 41640583
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Differentiation of Supraventricular Tachyarrhythmias by Questionnaire and High-resolution ECG in the Context of Ablation Treatment
- ClinicalTrials.gov ID
- NCT06061120
- Acronym / sponsor ID
- NIDSA / CTCA 21-083
- Conditions
- Supraventricular Arrhythmia, Atrial Fibrillation
- Keywords
- Electrocardiogram, Signal-averaged P-Wave, Questionnaire, Supraventricular Arrhythmia, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- Department of Internal Medicine I - Cardiology, KKS -Kardiologisches Klinisches Studienzentrum
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Questionnaire - Supraventricular arrhythmia | – | –Questionnaire about triggers and stops of supra ventricular arrhythmia |
| Extended ECG - Effect of electrophysiological ablation | – | Device: Recording of an extended high-resolution ECGExtended signal-averaged ECGs in patients with ablation of supra ventricular ablation |
| Extended ECG - Virtual atrial Electrocardiogram | – | Device: Recording of an extended high-resolution ECGImprove visualisation of atrial arrhythmia by means of extended signal-averaged ECGs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Scheduled for ablation of a supraventricular tachycardia (atrial fibrillation, typical atrial flutter, AV nodal reentry tachycardia, accessory pathway)
- majority
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of an extended high-resolution ECGRecording of an extended high-resolution ECG | Device | Extended ECG - Effect of electrophysiological ablation, Extended ECG - Virtual atrial Electrocardiogram |
Primary outcome
Triggers of supraventricular arrhythmia
Time frame: 2 years
Anamnestic and ECG measured triggers of supra ventricular arrhythmia
7 secondary outcomes
P-Wave duration
Time frame: 2 years
P-Wave amplitude
Time frame: 2 years
P-Wave PQ time (time mesaured from begin of P-wave to begin of Q-Peak)
Time frame: 2 years
Signal-averaged P-Wave sample entropy
Time frame: 2 years
Signal-averaged P-Wave shannon entropy
Time frame: 2 years
Signal-averaged P-Wave complexity
Time frame: 2 years
Visualisation of a signal-averaged P-Wave before and after catheter ablation with qualitative review of morphology
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 41640583Fantazi 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.
- Individual participant dataSharing planned: Yes. Data can be shared on reasonable request after data is already published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Gramlich contact
Matthias D Zink, MD principal investigator
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraventricular Arrhythmia and Atrial Fibrillation, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias D Zink, MD (00492418035113, mzink@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triggers of supraventricular arrhythmia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.