NCT07630480

Brief Summary

This prospective randomized interventional study compared conventional fluoroscopy-guided slow pathway ablation versus three-dimensional electroanatomical mapping-guided ablation in patients with electrophysiologically confirmed typical atrioventricular nodal re-entrant tachycardia (AVNRT). A total of 108 patients were screened for eligibility, of whom 80 eligible patients were randomized in a 1:1 ratio to either conventional fluoroscopic ablation or 3D mapping-guided ablation. Following post-randomization dropouts, the final analysis included 38 patients in the conventional group and 36 patients in the 3D mapping group. The study evaluated fluoroscopy exposure, procedural efficacy, complete slow pathway elimination, procedural success, complications, and arrhythmia recurrence during follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 30, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

May 23, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

AVNRTCatheter AblationElectrophysiologyThree-Dimensional MappingElectroanatomical MappingFluoroscopySlow Pathway Ablation

Outcome Measures

Primary Outcomes (2)

  • Total Fluoroscopy Radiation Dose During Catheter Ablation

    Total fluoroscopy radiation dose measured during the catheter ablation procedure, reported in mGy.

    At completion of the index ablation procedure

  • Total Fluoroscopy Exposure Time During Catheter Ablation

    Total duration of fluoroscopy exposure during the catheter ablation procedure, reported in minutes.

    At completion of the index ablation procedure

Secondary Outcomes (2)

  • Number of Participants With Complete Slow Pathway Elimination

    At completion of the index ablation procedure

  • Number of Participants with Acute Procedural Success

    At completion of the index ablation procedure

Study Arms (2)

Conventional Fluoroscopy-Guided Ablation

ACTIVE COMPARATOR

Patients underwent conventional fluoroscopy-guided slow pathway ablation using standard anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch.

Procedure: Conventional Slow Pathway Ablation

3D Electroanatomical Mapping-Guided Ablation

EXPERIMENTAL

Patients underwent three-dimensional electroanatomical mapping-guided slow pathway ablation using CARTO or EnSite X systems with integrated voltage, activation, and fractionated electrogram mapping.

Procedure: 3D Electroanatomical Mapping-Guided Ablation

Interventions

Conventional fluoroscopy-guided catheter ablation of the slow AV nodal pathway using anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch.

Also known as: Conventional Fluoroscopy-Guided Ablation
Conventional Fluoroscopy-Guided Ablation

Three-dimensional electroanatomical mapping-guided catheter ablation of the slow AV nodal pathway using CARTO or EnSite X systems with voltage and activation mapping guidance.

3D Electroanatomical Mapping-Guided Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sustained symptomatic supraventricular tachycardia with surface ECG features highly suggestive of atrioventricular nodal re-entrant tachycardia (AVNRT).
  • Electrophysiologically confirmed typical (slow-fast) AVNRT during the index electrophysiology study.
  • Ability to provide written informed consent.

You may not qualify if:

  • Coexisting arrhythmia requiring concurrent catheter ablation during the same procedure.
  • Non-inducible AVNRT at the time of electrophysiological study.
  • Antiarrhythmic drug use within 48 hours before the procedure or ongoing amiodarone therapy.
  • Hemodynamic instability precluding safe catheter manipulation.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafr Elsheikh Univfersity Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 11355, Egypt

Location

MeSH Terms

Conditions

Tachycardia, Atrioventricular Nodal ReentryTachycardia, Supraventricular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessment and follow-up evaluation were performed by investigators blinded to treatment allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Eligible patients with electrophysiologically confirmed typical AVNRT were randomized in a 1:1 ratio to either conventional fluoroscopy-guided slow pathway ablation or three-dimensional electroanatomical mapping-guided ablation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer at cardiology department, Kafr Elsheikh University

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 5, 2026

Study Start

December 30, 2023

Primary Completion

November 23, 2025

Study Completion

November 23, 2025

Last Updated

June 5, 2026

Record last verified: 2026-06

Locations