- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 11355
- Kafr Elsheikh Univfersity Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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.
Andre navn:
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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Fluoroscopy Radiation Dose During Catheter Ablation
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Complete Slow Pathway Elimination
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AVNRT-3D-2025
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