AV Nodal Reentrant Tachycardia Study (AVNRT)

May 8, 2023 updated by: University of Oklahoma

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.

Study Overview

Status

Active, not recruiting

Detailed Description

HYPOTHESES:

  1. 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)
  2. 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.
  3. 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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • The University of Oklahoma Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Study Arm
Mapping and Ablation
Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
raise the frequency of success to more than 98%
Time Frame: unk
unk

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deborah Lockwood, M.D., University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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