AV Nodal Reentrant Tachycardia Study
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Purpose
The purpose of this study is to determine/identify what mechanisms/factors are involved with regard to AV nodal reentrant tachycardia.
| Condition | Intervention |
|---|---|
|
Tachycardia, Atrioventricular Nodal Reentry |
Procedure: Cardiac Invasive Electrophysiological Study |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Localization of the Anterograde and Retrograde Components of the Reentrant Circuit of AV Nodal Reentrant Tachycardia |
- raise the frequency of success to more than 98% [ Time Frame: unk ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2004 |
| Estimated Study Completion Date: | March 2020 |
| Estimated Primary Completion Date: | March 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Study Arm
Mapping and Ablation
|
Procedure: Cardiac Invasive Electrophysiological Study
Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Deborah Lockwood, M.D. | 405-271 9696 ext 37531 | deborah-lockwood@ouhsc.edu |
| Contact: Kathy Drennan, RN | 405-271 2299 | kathy-drennan@ouhsc.edu |
| United States, Oklahoma | |
| The University of Oklahoma Health Sciences Center | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Kathy Drennan, RN 405-271-2299 Kathy-Drennan@ouhsc.edu | |
| Principal Investigator: Deborah Lockwood, M.D. | |
| Principal Investigator: | Deborah Lockwood, M.D. | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT00618683 History of Changes |
| Other Study ID Numbers: | 11255, AHA |
| Study First Received: | February 7, 2008 |
| Last Updated: | August 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
AVNRT Atrioventricular nodal reentrant circuit nodal reentrant tachycardia Paroxysmal supraventricular tachycardia |
Additional relevant MeSH terms:
|
Tachycardia Tachycardia, Atrioventricular Nodal Reentry Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Tachycardia, Reciprocating |
ClinicalTrials.gov processed this record on June 18, 2013