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- Essai clinique NCT00111527
APAF: Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation
An Assessment of the Echo-guided Optimal Cardiac Resynchronization Therapy in Patients Undergoing 'Ablate And Pace' Therapy for Permanent Atrial Fibrillation
A suboptimal level of resynchronization (cardiac resynchronization therapy [CRT]) achieved in many patients with actual standards and techniques based on tissue-Doppler echocardiography could be more effective to obtain better CRT results. Eligible patients who successfully received atrioventricular (AV) junction ablation and biventricular (BiV) pacing are randomised to a comparison between a strategy of right ventricular (RV) apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification.
End-points:
- Acute echo comparison (acute echo study)
- Quality of life and exercise tolerance (Short-term clinical study)
- Composite end-point of CRT clinical failure (Long-term clinical study)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Cardiac resynchronization therapy (CRT) in patients in atrial fibrillation (AF) seems to provide modest favorable effect compared with RV pacing. In the Optimal Pacing SITE (OPSITE) trial the results were heterogeneous. The situation was almost certainly one in which some patients are showing marked clinical benefit with LV-based pacing, balanced by other patients in whom RV was the best choice. Therefore with the actual standards, CRT pacing cannot be recommended as a first line treatment for all patients with AF and refractory heart failure and new criteria to identify the patients who might benefit are needed. Furthermore, a pre-requisite for CRT in patients with AF is the presence of stable 3rd degree AV block which usually implies the need for performing catheter ablation of the AV junction.
Study hypothesis: We hypothesized that a suboptimal level of resynchronization is achieved in many patients with actual standards and that some techniques based on tissue-Doppler echocardiography could be more effective to obtain better (hopefully optimal) CRT results.
Objective: The aim of the APAF+ heart failure (HF) trial is to compare, in patients affected by permanent AF and refractory heart failure, a strategy of delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification.
Study protocol: Eligible patients who successfully received AV junction ablation and biventricular pacing are randomised to a comparison between a strategy of RV apical pacing with delayed CRT based on clinical indications with a strategy of early optimal CRT based on an echocardiographic stratification. The optimal CRT is defined as the shortest intra-LV delay obtained with tissue-doppler echocardiography among RV, LV and BiV optimised VV interval.
An acute echocardiographic evaluation is performed shortly after randomisation. A short-term clinical evaluation is performed after 6 months. A long-term clinical evaluation is performed up to 24 months.
End-points:
- Acute echo comparison (acute echo study)
- Quality of life and exercise tolerance (Short-term clinical study)
- Composite end-point of CRT clinical failure (Long-term clinical study)
Study size: The study will randomise 458 patients and will be conducted in 46 centres with an average of 10 patients per centre. Patient enrolment time is anticipated to last 2 years. As the study will continue for a period of 12 months after the enrolment of the last patient, total study duration will be approximately 3 years.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Reggio Emilia, Italie, 42100
- Arcispedale S Maria Nuova
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Genova
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Lavagna, Genova, Italie, 16033
- Michele Brignole
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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:
- Patients with permanent AF in whom a clinical decision had been made to undertake complete AV junction ablation and ventricular pacing because of drug-refractory, severely symptomatic, uncontrolled high ventricular rate
- Patients with permanent AF, drug-refractory heart failure, depressed LV function in whom a clinical decision had been made to undertake left ventricular synchronization pacing
Exclusion Criteria:
- New York Heart Association class IV heart failure, or systolic blood pressure ≥80 mmHg
- Severe concomitant non cardiac disease
- Need for surgical intervention
- Myocardial infarction within 3 months
- Primary hypertrophic cardiomyopathy
- Arrhythmogenic right ventricular dysplasia
- Primary valvular heart disease
- Sustained ventricular tachycardia or ventricular fibrillation
- Previously implanted pacemaker
- Inability to obtain reliable RV and LV pacing and persistent AV block
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 1
Normal RV pacing
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PM or ICD implant according to patient indication
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Expérimental: 2
Echo-guided optimization of pacing
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Echo-TDI guided VV-delay optimization
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Short-term clinical study (6 months): Quality of life (measured as Minnesota Living with Heart Failure Questionnaire, Specific Symptom Scale and New York Heart Association classification) and exercise capacity at 6 months in the 2 study groups
Délai: 6 months
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6 months
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Long-term clinical study (24 months): Composite end-point of: death due to cardiovascular cause, hospitalisation for worsening heart failure, worsening heart failure or failure to achieve a persistent subjective symptom improvement (clinical failure)
Délai: 24 months
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24 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
The evaluation of the predictive value of echo desynchronisation indexes (inter and intra-LV delays) for identification of clinical failure (see above)
Délai: 24 months
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24 months
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Cost-benefit comparison of the 2 pacing strategies
Délai: 24 months
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24 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Michele Brignole, MD, Ospedali del Tigullio, Lavagna, Italy
- Chercheur principal: Carlo Menozzi, MD, Ospedale S Maria Nuova, Reggio Emilia, Italy
Publications et liens utiles
Publications générales
- Auricchio A, Abraham WT. Cardiac resynchronization therapy: current state of the art: cost versus benefit. Circulation. 2004 Jan 27;109(3):300-7. doi: 10.1161/01.CIR.0000115583.20268.E1. No abstract available.
- Brignole M, Gammage M, Puggioni E, Alboni P, Raviele A, Sutton R, Vardas P, Bongiorni MG, Bergfeldt L, Menozzi C, Musso G; Optimal Pacing SITE (OPSITE) Study Investigators. Comparative assessment of right, left, and biventricular pacing in patients with permanent atrial fibrillation. Eur Heart J. 2005 Apr;26(7):712-22. doi: 10.1093/eurheartj/ehi069. Epub 2004 Dec 20.
- Wood MA, Brown-Mahoney C, Kay GN, Ellenbogen KA. Clinical outcomes after ablation and pacing therapy for atrial fibrillation : a meta-analysis. Circulation. 2000 Mar 14;101(10):1138-44. doi: 10.1161/01.cir.101.10.1138.
- Brignole M, Botto G, Mont L, Iacopino S, De Marchi G, Oddone D, Luzi M, Tolosana JM, Navazio A, Menozzi C. Cardiac resynchronization therapy in patients undergoing atrioventricular junction ablation for permanent atrial fibrillation: a randomized trial. Eur Heart J. 2011 Oct;32(19):2420-9. doi: 10.1093/eurheartj/ehr162. Epub 2011 May 23.
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
- 1893A
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