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3D Mapping Versus Conventional Ablation in AVNRT (MAP-AVNRT)

1 juni 2026 bijgewerkt door: Soha Mahmoud Ali Elshibly, Kafrelsheikh University

Three-Dimensional Electroanatomical Mapping Versus Conventional Fluoroscopy-Guided Slow Pathway Ablation for Typical Atrioventricular Nodal Re-Entrant Tachycardia: A Prospective Randomized Study

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.

Studie Overzicht

Gedetailleerde beschrijving

Atrioventricular nodal re-entrant tachycardia (AVNRT) is one of the most common forms of paroxysmal supraventricular tachycardia. Catheter ablation targeting the slow AV nodal pathway is considered definitive therapy with high procedural success rates.

Conventional fluoroscopy-guided ablation mainly relies on anatomical landmarks and intracardiac electrogram interpretation. However, fluoroscopy exposure remains an important concern for both patients and operators. Three-dimensional electroanatomical mapping systems allow detailed reconstruction of the triangle of Koch and facilitate substrate-guided ablation using voltage, activation, and fractionated electrogram mapping techniques. These systems may reduce fluoroscopy exposure and improve procedural precision and efficacy.

This prospective randomized two-arm interventional study was conducted at the Cardiology Department, Kafr El-Sheikh University Hospital, between December 2023 and November 2025. A total of 108 consecutive patients with symptomatic supraventricular tachycardia suggestive of AVNRT were screened for eligibility. Following assessment according to predefined inclusion and exclusion criteria, 80 eligible patients with electrophysiologically confirmed typical AVNRT were enrolled and randomized in a 1:1 ratio to either conventional fluoroscopy-guided slow pathway ablation (Conventional group, n = 40) or three-dimensional electroanatomical mapping-guided slow pathway ablation (3D group, n = 40).

During the study period, post-randomization dropouts and exclusions occurred in both groups. Consequently, the final analysis included 38 patients in the conventional ablation group and 36 patients in the 3D mapping-guided ablation group.

In the conventional arm, ablation was performed using standard fluoroscopic anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch. In the 3D mapping arm, high-density electroanatomical mapping using CARTO or EnSite X systems was performed with integrated voltage, activation, and fractionated electrogram mapping to identify optimal ablation targets.

Primary outcomes included fluoroscopy time, fluoroscopy dose, complete slow pathway elimination, and procedural success defined as non-inducibility of sustained AVNRT after ablation. Secondary outcomes included total procedure duration, number and duration of radiofrequency applications, complications, recurrence during follow-up, hospital stay duration, need for redo ablation, and predictors of complete slow pathway elimination.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Kafr el-Sheikh Governorate
      • Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypte, 11355
        • Kafr Elsheikh Univfersity Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Conventional Fluoroscopy-Guided Ablation
Patients underwent conventional fluoroscopy-guided slow pathway ablation using standard anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch.
Conventional fluoroscopy-guided catheter ablation of the slow AV nodal pathway using anatomical landmarks and intracardiac electrogram criteria within the triangle of Koch.
Andere namen:
  • Conventional Fluoroscopy-Guided Ablation
Experimenteel: 3D Electroanatomical Mapping-Guided Ablation
Patients underwent three-dimensional electroanatomical mapping-guided slow pathway ablation using CARTO or EnSite X systems with integrated voltage, activation, and fractionated electrogram mapping.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Total Fluoroscopy Radiation Dose During Catheter Ablation
Tijdsspanne: At completion of the index ablation procedure
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
Tijdsspanne: At completion of the index ablation procedure
Total duration of fluoroscopy exposure during the catheter ablation procedure, reported in minutes.
At completion of the index ablation procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Complete Slow Pathway Elimination
Tijdsspanne: At completion of the index ablation procedure
Complete abolition of slow pathway conduction and disappearance of the anterograde AH jump following catheter ablation.
At completion of the index ablation procedure
Number of Participants with Acute Procedural Success
Tijdsspanne: At completion of the index ablation procedure
Acute procedural success defined as non-inducibility of sustained AVNRT after catheter ablation under baseline conditions and following isoproterenol infusion.
At completion of the index ablation procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 december 2023

Primaire voltooiing (Werkelijk)

23 november 2025

Studie voltooiing (Werkelijk)

23 november 2025

Studieregistratiedata

Eerst ingediend

23 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

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ONBESLIST

Beschrijving IPD-plan

Individual participant data (IPD) sharing plans have not yet been finalized at the time of study registration.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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