AV Nodal Reentrant Tachycardia Study (AVNRT)
Primary Purpose
Tachycardia, Atrioventricular Nodal Reentry
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Invasive Electrophysiological Study
Sponsored by
About this trial
This is an interventional diagnostic trial for Tachycardia, Atrioventricular Nodal Reentry focused on measuring AVNRT, Atrioventricular, nodal reentrant circuit, nodal reentrant tachycardia, Paroxysmal supraventricular tachycardia
Eligibility Criteria
Inclusion Criteria:
- Ages 16-80
- At least one documented episode of AV nodal reentrant tachycardia
- Patient scheduled for electrophysiology study and catheter ablation for supraventricular tachycardia
Exclusion Criteria:
- 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
Sites / Locations
- The University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study Arm
Arm Description
Mapping and Ablation
Outcomes
Primary Outcome Measures
raise the frequency of success to more than 98%
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00618683
Brief Title
AV Nodal Reentrant Tachycardia Study
Acronym
AVNRT
Official Title
Localization of the Anterograde and Retrograde Components of the Reentrant Circuit of AV Nodal Reentrant Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Atrioventricular Nodal Reentry
Keywords
AVNRT, Atrioventricular, nodal reentrant circuit, nodal reentrant tachycardia, Paroxysmal supraventricular tachycardia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Other
Arm Description
Mapping and Ablation
Intervention Type
Procedure
Intervention Name(s)
Cardiac Invasive Electrophysiological Study
Intervention Description
Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study
Primary Outcome Measure Information:
Title
raise the frequency of success to more than 98%
Time Frame
unk
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 16-80
At least one documented episode of AV nodal reentrant tachycardia
Patient scheduled for electrophysiology study and catheter ablation for supraventricular tachycardia
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Lockwood, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
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AV Nodal Reentrant Tachycardia Study
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