NCT04764123

Brief Summary

This study is aimed at :

  1. 1.Identifying the exact location of the circuit of typical and atypical AVNRT by applying high-resolution electroanatomic mapping.
  2. 2.Investigating the possibility that the recently described "ring tissues" participate in the AVNRT circuit.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

January 23, 2021

Last Update Submit

February 24, 2021

Conditions

Keywords

AtrioventricularNodal ReentryTachycardia

Outcome Measures

Primary Outcomes (1)

  • Participation of ring tissues in the AVNRT Circuit

    Tachycardia entrainment by pacing at the anatomical ring tissue site or tachycardia termination with successful ablation at the ring tissue site

    2 years

Secondary Outcomes (1)

  • Fast and slow pathway activation time in the circuit of AVNRT.

    2 years

Study Arms (1)

AVNRT Cohort

Patients admitted for electrophysiological study and ablation due to AVNRT tachycardia. During the study and before the ablation high density electroanatomical mapping will be performed.

Diagnostic Test: AVNRT mapping

Interventions

AVNRT mappingDIAGNOSTIC_TEST

AV annuli mapping during AVNRT

Also known as: Electroanatomic mapping
AVNRT Cohort

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with typical or atypical AVNRT admitted for electrophysiological study and ablation.

You may qualify if:

  • Patients with atypical or typical AVNRT
  • Patients able to provide informed consent

You may not qualify if:

  • Age \<16 or \>75 years
  • Known heart failure
  • Severe comorbidities with estimated life expectancy \< 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal ReentryTachycardia

Condition Hierarchy (Ancestors)

Tachycardia, ReciprocatingArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Demosthenes G Katritsis, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 23, 2021

First Posted

February 21, 2021

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 25, 2021

Record last verified: 2021-02