Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation (AF-FII)
Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.
The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.
The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Saxony
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Dresden, Saxony, Allemagne, 01307
- Department of Electrophysiology, University of Dresden - Heart Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- documented atrial fibrillation in the 12-lead ECG or Holter ECG
- Paroxysmal symptomatic atrial fibrillation
- Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
- Age 18-75 years
- left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
- A signed consent form
Exclusion Criteria:
- Reversible etiology of atrial fibrillation
- Pregnancy
- Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
- Intracardiac thrombus
- Contraindication to anticoagulation
- Thromboembolic event in the last 6 months
- Previous left atrial ablation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: CARTOUNIVU
Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system
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Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
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Comparateur actif: CARTO3
Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique
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Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fluoroscopy time for each step of atrial fibrillation ablation procedure
Délai: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
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1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Fluoroscopy doses for each step of atrial fibrillation ablation procedure
Délai: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
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1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of patients with adverse events as a measure of safety
Délai: All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
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Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.
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All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
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Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
Délai: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
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number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation
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1 day ( at the end of each step of atrial fibrillation ablation procedure)
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Total time of atrial fibrillation ablation procedure as a measure of efficacy
Délai: up to 24 hours
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procedure time (minute)
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up to 24 hours
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christopher Piorkowski, M.D., Department of Electrophysiology, University of Dresden - Heart Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EK474122013
- CARTOUNIVU (Autre subvention/numéro de financement: Biosense Webster)
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