Tachycardia, Atrioventricular Nodal ReentryAVNRTNCT00618683
AV Nodal Reentrant Tachycardia Study
A study testing Cardiac Invasive Electrophysiological Study in people with Tachycardia, Atrioventricular Nodal Reentry, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to determine/identify what mechanisms/factors are involved with regard to AV nodal reentrant tachycardia. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Tachycardia, Atrioventricular Nodal Reentry
- What is being tested?
- Cardiac Invasive Electrophysiological Study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2004to 12 Jan 2021
- Phase
- Interventional
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 16-80
- At least one documented episode of AV nodal reentrant tachycardia
- Patient scheduled for electrophysiology study and catheter ablation for supraventricular tachycardia
Who cannot join
- Ages < 16 or > 80
- Medical condition significantly increasing risk of extending procedure time or X-ray exposure
- Pregnancy
- Prior ablation with radiation exposure >2 hours
- Electrophysiology study performed without sedation or anesthesia
- Unavailable for follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Localization of the Anterograde and Retrograde Components of the Reentrant Circuit of AV Nodal Reentrant Tachycardia
The purpose of this study is to determine/identify what mechanisms/factors are involved with regard to AV nodal reentrant tachycardia.
Read the detailed description
HYPOTHESES:
- The Tendon of Todaro forms a line of block during slow/fast AVNRT preventing the atrial impulse from entering the triangle of Koch (and perhaps providing sufficient time for activation to pass through the coronary sinus coat to activate the posterior extensions of the AV node as is critical to maintenance of tachycardia)
- The coronary sinus myocardial coat participates in all of the forms of AVNRT. The reentrant circuit is thus not confined within the triangle of Koch and sites remote from the compact AV node could be targeted for ablation reducing the risk of AV conduction block.
- A model of the reentrant circuit can be created for each patient's tachycardia, using the site of earliest retrograde activation to suggest the retrograde limb and the resetting response to suggest the anterograde limb.
DATA ANALYSIS/STATISTICS:
Resetting and Mapping of AV nodal reentrant tachycardia:
Pacing will be analyzed to see at which sites, the tachycardia can be reset by the latest extra-stimuli (i.e., with the least advancement in local activation). The coupling interval will be compared to the latest extra-stimulus capable of resetting (advancing) the tachycardia from the postero-septal tricuspid annulus.
Ablation Results:
The patients will act as their own reference, since the standard ablation technique in the postero-septal space is being performed first and tested for efficacy. The McNemar test will be applied to compare the efficacy of ablation at the postero-septal tricuspid annulus alone (standard ablation), with the efficacy of this ablation plus ablation within the coronary sinus. From our initial observations, It is anticipated that the additional ablation in the coronary sinus will increase the efficacy of the procedure from <95% to >98%, such that 100 cases should provide sufficient data to reach statistical significance.
- Being tested
- Cardiac Invasive Electrophysiological Study
- Keywords
- AVNRT, Atrioventricular, nodal reentrant circuit, nodal reentrant tachycardia, Paroxysmal supraventricular tachycardia
- Medical subject headings
- Tachycardia, Atrioventricular Nodal Reentry, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Invasive Electrophysiological StudyProcedure or surgery
Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Other | Mapping and Ablation Receives: Procedure: Cardiac Invasive Electrophysiological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
raise the frequency of success to more than 98%
Measured: unk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study start25 Mar 2004
- Primary completion21 Jan 2020
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tachycardia, Atrioventricular Nodal ReentryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stavros Stavrakis, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618683
- Sponsor's protocol ID
- 2353
- Other IDs
- AHA
- Acronym
- AVNRT
- Status last verified
- May 2024
- First submitted
- 7 Feb 2008
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localization of the Anterograde and Retrograde Components of the Reentrant Circuit of AV Nodal Reentrant Tachycardia
- ClinicalTrials.gov ID
- NCT00618683
- Acronym / sponsor ID
- AVNRT / 2353
- Keywords
- AVNRT, Atrioventricular, nodal reentrant circuit, nodal reentrant tachycardia, Paroxysmal supraventricular tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 25 Mar 2004 (actual)
- Primary completion
- 21 Jan 2020 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 20 Feb 2008 (estimated)
- 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.
The purpose of this study is to determine/identify what mechanisms/factors are involved with regard to AV nodal reentrant tachycardia.
Detailed description
HYPOTHESES:
- The Tendon of Todaro forms a line of block during slow/fast AVNRT preventing the atrial impulse from entering the triangle of Koch (and perhaps providing sufficient time for activation to pass through the coronary sinus coat to activate the posterior extensions of the AV node as is critical to maintenance of tachycardia)
- The coronary sinus myocardial coat participates in all of the forms of AVNRT. The reentrant circuit is thus not confined within the triangle of Koch and sites remote from the compact AV node could be targeted for ablation reducing the risk of AV conduction block.
- A model of the reentrant circuit can be created for each patient's tachycardia, using the site of earliest retrograde activation to suggest the retrograde limb and the resetting response to suggest the anterograde limb.
DATA ANALYSIS/STATISTICS:
Resetting and Mapping of AV nodal reentrant tachycardia:
Pacing will be analyzed to see at which sites, the tachycardia can be reset by the latest extra-stimuli (i.e., with the least advancement in local activation). The coupling interval will be compared to the latest extra-stimulus capable of resetting (advancing) the tachycardia from the postero-septal tricuspid annulus.
Ablation Results:
The patients will act as their own reference, since the standard ablation technique in the postero-septal space is being performed first and tested for efficacy. The McNemar test will be applied to compare the efficacy of ablation at the postero-septal tricuspid annulus alone (standard ablation), with the efficacy of this ablation plus ablation within the coronary sinus. From our initial observations, It is anticipated that the additional ablation in the coronary sinus will increase the efficacy of the procedure from <95% to >98%, such that 100 cases should provide sufficient data to reach statistical significance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Other | Procedure: Cardiac Invasive Electrophysiological StudyMapping and Ablation |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 16-80
- At least one documented episode of AV nodal reentrant tachycardia
- Patient scheduled for electrophysiology study and catheter ablation for supraventricular tachycardia
Key exclusion criteria (6 listed)
- Ages < 16 or > 80
- Medical condition significantly increasing risk of extending procedure time or X-ray exposure
- Pregnancy
- Prior ablation with radiation exposure >2 hours
- Electrophysiology study performed without sedation or anesthesia
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 |
|---|---|---|
| Cardiac Invasive Electrophysiological StudyMapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study | Procedure or surgery | Study Arm |
Primary outcome
raise the frequency of success to more than 98%
Time frame: unk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 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. This study is not recruiting at the moment.
Stavros Stavrakis, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Invasive Electrophysiological Study in people with Tachycardia, Atrioventricular Nodal Reentry, run by University of Oklahoma at 1 site in United States.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 10 May 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
raise the frequency of success to more than 98% (time frame: unk). 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 10 May 2024.