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3D Mapping Versus Conventional Ablation in AVNRT (MAP-AVNRT)
Three-Dimensional Electroanatomical Mapping Versus Conventional Fluoroscopy-Guided Slow Pathway Ablation for Typical Atrioventricular Nodal Re-Entrant Tachycardia: A Prospective Randomized Study
Studie Overzicht
Toestand
Interventie / Behandeling
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypte, 11355
- Kafr Elsheikh Univfersity Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
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
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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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.
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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:
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Total Fluoroscopy Radiation Dose During Catheter Ablation
Tijdsspanne: At completion of the index ablation procedure
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Total fluoroscopy radiation dose measured during the catheter ablation procedure, reported in mGy.
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At completion of the index ablation procedure
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Total Fluoroscopy Exposure Time During Catheter Ablation
Tijdsspanne: At completion of the index ablation procedure
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Total duration of fluoroscopy exposure during the catheter ablation procedure, reported in minutes.
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At completion of the index ablation procedure
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of Participants With Complete Slow Pathway Elimination
Tijdsspanne: At completion of the index ablation procedure
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Complete abolition of slow pathway conduction and disappearance of the anterograde AH jump following catheter ablation.
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At completion of the index ablation procedure
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Number of Participants with Acute Procedural Success
Tijdsspanne: At completion of the index ablation procedure
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Acute procedural success defined as non-inducibility of sustained AVNRT after catheter ablation under baseline conditions and following isoproterenol infusion.
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At completion of the index ablation procedure
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AVNRT-3D-2025
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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