- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07630480
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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egitto, 11355
- Kafr Elsheikh Univfersity Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
Altri nomi:
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Fluoroscopy Radiation Dose During Catheter Ablation
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Complete Slow Pathway Elimination
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AVNRT-3D-2025
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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