SVTNCT06671145
Differentiate AVNRT from Orthodromic AVRT
A study testing catheter ablation in people with SVT, run by Assiut University.
Trial summary
To study new maneuvers to differentiate AVNRT from orthodromic AVRT including VA interval variability at tachycardia induction, SA-VA base and local VA index (difference between local VA interval, measured on the coronary sinus catheter during tachycardia and entrainment, at the site of earliest atrial activity). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SVT
- What is being tested?
- catheter ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 10 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with documented narrow complex supraventricular tachycardia presented to electrophysiology lab including all age and sex patients (in Assiut university cath. lab) and proved to be AVNRT or orthodromic AVRT.
Who cannot join
- Atrial tachycardia
- Atrial flutter.
- Atrial fibrillation.
- Manifest preexcitation on surface ECG -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study of New Simple Maneuvers for Differentiating Atrioventricular Nodal Reentry Tachycardia from Orthodromic Atrioventricular Reentry Tachycardia During Electrophysiological Study
To study new maneuvers to differentiate AVNRT from orthodromic AVRT including VA interval variability at tachycardia induction, SA-VA base and local VA index (difference between local VA interval, measured on the coronary sinus catheter during tachycardia and entrainment, at the site of earliest atrial activity).
Read the detailed description
The differentiation of atrioventricular nodal reentrant tachycardia (AVNRT) from atrioventricular reciprocating tachycardia (AVRT) as well as the localization of accessory pathways (APs) is necessary to guide the catheter ablation of supraventricular tachycardia (SVT). However, existing techniques may prove challenging in differentiating atypical forms of AVNRT from AVRT using a septal AP; or localizing AVRT with different septal AP insertion sites.
There are many diagnostic maneuvers during electrophysiological study eg ventriculo atrial interval (VA) during tachycardia, postpacing interval tachycardia cycle length (PPI-TCL) and stimulus atrial ventriculaoatrial interval (SA-VA). It is important to recognize that as with most diagnostic tests, no single observation or maneuver is 100% sensitive or specific. Therefore, it is important to obtain data from multiple observations and maneuvers to verify the diagnosis.
Also, utility of these techniques usually depends on the tachycardia to be sustained, however sometimes tachycardia is rapidly terminating. VA interval at initiation of tachycardia is usually variable and becomes fixed after several beats. This may be explained by differences in retrograde conduction between AVRT and AVNRT which may be better exposed at the time of tachycardia induction, So measuring the number of beats until VA becomes fixed may theoretically help in differentiating AVNRT from AVRT.
Although several reports have demonstrated the usefulness of the SA-VA using right ventricular (RV) apical stimulation (SA-VAapex) to distinguish AVNRT from AVRT, there remains significant overlap in the SA-VA complicating the distinction between these 2 arrhythmias.
Theoretically, stimulation from the RV basal septum (SA-VAbase) would be expected to shorten the SA interval in AVRT because atrioventricular pathways insert in the ventricular base. On the other hand, the SA-VAbase should have the opposite effect on AVNRT because the impulse must first pass from the RV base to the apex to access the right bundle.
- Conditions
- SVT
- Being tested
- catheter ablation
- Keywords
- AVNRT - orthodromic AVRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter ablationDiagnostic test
Catheter ablation after differentiating Atrioventricular Nodal Reentry Tachycardia from Orthodromic Atrioventricular Reentry Tachycardia during electrophysiological study.
| Study group | Role | What they receive |
|---|---|---|
| group (1)catheter ablation after diagnosis of Atrioventricular Nodal Reentry Tachycardia | Active comparator | diagnosis Atrioventricular Nodal Reentry Tachycardia before catheter ablation Receives: Diagnostic Test: catheter ablation |
| group (2) catheter ablation after diagnosis of orthodromic Atrioventricular Reentry Tachycardia | Active comparator | diagnosis of orthodromic Atrioventricular Reentry Tachycardia before catheter ablation Receives: Diagnostic Test: catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To differentiate between narrow complex supraventricular tachycardia (AVNRT from orthodromic AVRT during electrothysiological study).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start31 Oct 2024 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SVTStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam El Din Mohamed Farghaly, Assiut University
- Investigators
- Doaa Ahmed Fouad, pro, Principal investigator, Assiut UniversityHeba Mahmoud Abdel Mohsen El- naggar, Ass. pro, Principal investigator, Assiut Universitymarwan sayed mahmoud, doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671145
- Sponsor's protocol ID
- AVNRT and orthodromic AVRT
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of New Simple Maneuvers for Differentiating Atrioventricular Nodal Reentry Tachycardia from Orthodromic Atrioventricular Reentry Tachycardia During Electrophysiological Study
- ClinicalTrials.gov ID
- NCT06671145
- Acronym / sponsor ID
- AVNRT and orthodromic AVRT
- Conditions
- SVT
- Keywords
- AVNRT - orthodromic AVRT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 4 Nov 2024 (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.
To study new maneuvers to differentiate AVNRT from orthodromic AVRT including VA interval variability at tachycardia induction, SA-VA base and local VA index (difference between local VA interval, measured on the coronary sinus catheter during tachycardia and entrainment, at the site of earliest atrial activity).
Detailed description
The differentiation of atrioventricular nodal reentrant tachycardia (AVNRT) from atrioventricular reciprocating tachycardia (AVRT) as well as the localization of accessory pathways (APs) is necessary to guide the catheter ablation of supraventricular tachycardia (SVT). However, existing techniques may prove challenging in differentiating atypical forms of AVNRT from AVRT using a septal AP; or localizing AVRT with different septal AP insertion sites.
There are many diagnostic maneuvers during electrophysiological study eg ventriculo atrial interval (VA) during tachycardia, postpacing interval tachycardia cycle length (PPI-TCL) and stimulus atrial ventriculaoatrial interval (SA-VA). It is important to recognize that as with most diagnostic tests, no single observation or maneuver is 100% sensitive or specific. Therefore, it is important to obtain data from multiple observations and maneuvers to verify the diagnosis.
Also, utility of these techniques usually depends on the tachycardia to be sustained, however sometimes tachycardia is rapidly terminating. VA interval at initiation of tachycardia is usually variable and becomes fixed after several beats. This may be explained by differences in retrograde conduction between AVRT and AVNRT which may be better exposed at the time of tachycardia induction, So measuring the number of beats until VA becomes fixed may theoretically help in differentiating AVNRT from AVRT.
Although several reports have demonstrated the usefulness of the SA-VA using right ventricular (RV) apical stimulation (SA-VAapex) to distinguish AVNRT from AVRT, there remains significant overlap in the SA-VA complicating the distinction between these 2 arrhythmias.
Theoretically, stimulation from the RV basal septum (SA-VAbase) would be expected to shorten the SA interval in AVRT because atrioventricular pathways insert in the ventricular base. On the other hand, the SA-VAbase should have the opposite effect on AVNRT because the impulse must first pass from the RV base to the apex to access the right bundle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group (1)catheter ablation after diagnosis of Atrioventricular Nodal Reentry Tachycardia | Active comparator | Diagnostic Test: catheter ablationdiagnosis Atrioventricular Nodal Reentry Tachycardia before catheter ablation |
| group (2) catheter ablation after diagnosis of orthodromic Atrioventricular Reentry Tachycardia | Active comparator | Diagnostic Test: catheter ablationdiagnosis of orthodromic Atrioventricular Reentry Tachycardia before catheter ablation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with documented narrow complex supraventricular tachycardia presented to electrophysiology lab including all age and sex patients (in Assiut university cath. lab) and proved to be AVNRT or orthodromic AVRT.
Key exclusion criteria (4 listed)
- Atrial tachycardia
- Atrial flutter.
- Atrial fibrillation.
- Manifest preexcitation on surface ECG -
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 |
|---|---|---|
| catheter ablationCatheter ablation after differentiating Atrioventricular Nodal Reentry Tachycardia from Orthodromic Atrioventricular Reentry Tachycardia during electrophysiological study. | Diagnostic test | group (1)catheter ablation after diagnosis of Atrioventricular Nodal Reentry Tachycardia, group (2) catheter ablation after diagnosis of orthodromic Atrioventricular Reentry Tachycardia |
Primary outcome
To differentiate between narrow complex supraventricular tachycardia (AVNRT from orthodromic AVRT during electrothysiological study).
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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.
Doaa Ahmed Fouad, pro principal investigator
Assiut University
Heba Mahmoud Abdel Mohsen El- naggar, Ass. pro principal investigator
Assiut University
marwan sayed mahmoud, doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing catheter ablation in people with SVT, run by Assiut University.
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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam EL Din mohamed, Resident (+20 01125970318 ext. +20 0112597031, hossammo198@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To differentiate between narrow complex supraventricular tachycardia (AVNRT from orthodromic AVRT during electrothysiological study). (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2024.