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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kafr el-Sheikh Governorate
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Kafr ash Shaykh、Kafr el-Sheikh Governorate、エジプト、11355
- Kafr Elsheikh Univfersity Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ: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.
他の名前:
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実験的: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Fluoroscopy Radiation Dose During Catheter Ablation
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Complete Slow Pathway Elimination
時間枠: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
時間枠: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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AVNRT-3D-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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