AV Nodal Reentrant Tachycardia Study | NCT00618683

Studies
AV Nodal Reentrant Tachycardia Study

NCT00618683

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

May 10, 2024Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Tachycardia, Atrioventricular Nodal Reentry

Interventions

Cardiac Invasive Electrophysiological Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AHA	Other Identifier	American Heart Association

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2004Actual

Primary Completion Date

Jan 21, 2020Actual

Completion Date

Jan 12, 2021Actual

First Submitted Date

Feb 7, 2008

First Submission Date that Met QC Criteria

Feb 19, 2008

First Posted Date

Feb 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2024

Last Update Posted Date

May 10, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Arm	Other	Mapping and Ablation	Procedure: Cardiac Invasive Electrophysiological Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Invasive Electrophysiological Study	Procedure	Mapping and localizing of the components of the reentrant circuit as part of the Electrophysiological Study	Study Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stavros Stavrakis, MD	University of Oklahoma	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Oklahoma Health Sciences Center		Oklahoma City	Oklahoma	73104	United States

Condition Browse Module

MeSH Terms

ID	Term
D013611	Tachycardia, Atrioventricular Nodal Reentry
D017180	Tachycardia, Ventricular

Ancestor Terms

ID	Term
D054139	Tachycardia, Reciprocating
D013610	Tachycardia
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases

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Browse Branches

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