Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)
Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Comprehensive study, prospective, monocentric and cohort study.
Biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. Among others, optimization of Left Ventricle (LV) pacing site location is critical to optimize response to Cardiac Resynchronization Therapy (CRT). Whether a better comprehension of baseline LV electrical activation can help to determine optimal LV lead location remains to be investigated.
After informed consent patients are included in the sudy. Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the LV cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Quantitative parameters: Global LV activation time (LVATG) (primary outcome); septal activation time (LVTAS); Global intra-LV dispersion time and Qualitative parameters: presence of intraLV line of block, area of late activation. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. A 3 and 6 months follow-up visit including clinical, biological evaluation (NYHA status, 6-min walking test, BNP) of the patients will be performed with an additional transthoracic echocardiography at 6 months.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Pessac, France, 33604
- Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor
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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:
- Adult (aged 18 or above)
- Sinus rhythm
- Patient must have signed informed consent
- Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
- Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation
- Left ventricular ejection fraction <35%
- NYHA Class II to IV with optimal medical treatment
- Patient covered by national healthcare insurance
Exclusion Criteria:
- Pregnant woman
- Sequel of transmural myocardial infarction
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intraventricular Electrical Activation
|
Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT).
Délai: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number, area and location of line of conduction block in the Left Ventricle
Délai: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
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Area of the latest activated region of the Left Ventricle
Délai: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Number, area and location of LV region activated after the end of surface QRS
Délai: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
|
Septal activation time (LVTAS)
Délai: Day 1 : End of CRT device implantation
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Day 1 : End of CRT device implantation
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Global intra-Left Ventricular dispersion time
Délai: Day 1 : End of CRT device implantation
|
Day 1 : End of CRT device implantation
|
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Determination of the electrical parameters associated with good clinical response to CRT at 6 months.
Délai: 6 months after CRT device implantation
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6 months after CRT device implantation
|
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Non-invasive mapping: Same criteria evaluated non-invasively using CardioInsight ® with and without Cardiac Resynchronization Therapy activated.
Délai: Between 3 to 7 days after CRT device implantation
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Between 3 to 7 days after CRT device implantation
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
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
- CHUBX 2010/29
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