AV Nodal Reentrant Tachycardia Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Oklahoma
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00618683
First received: February 7, 2008
Last updated: August 16, 2012
Last verified: August 2012
  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

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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:

  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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618683

Contacts
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

Locations
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.         
Sponsors and Collaborators
University of Oklahoma
Investigators
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 October 01, 2014