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Completed

NCT Number: NCT00618683

AV Nodal Reentrant Tachycardia Study

The purpose of this study is to determine/identify what mechanisms/factors are involved with regard to AV nodal reentrant tachycardia.

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Key information

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Invasive Electrophysiological Study

Procedure

Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study

Primary outcomes

  1. raise the frequency of success to more than 98%

    Time frame: unk

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Localization of the Anterograde and Retrograde Components of the Reentrant Circuit of AV Nodal Reentrant Tachycardia

Acronym: AVNRT

Important dates

Study start
2004
Primary completion
2020
Study completion
2021
First posted
Feb 20, 2008
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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