Izolace kryobalonových plicních žil u pacientů doporučených pro typickou ablaci flutteru síní (PAF CRIOBLAF)
Prevence fibrilace síní kombinovanou ablací pravého isthmu a kryobalonovou izolací plicních žil u pacientů s typickým flutterem síní
- Background:
Atrial fibrillation is frequently associated with typical atrial flutter in clinical practice. If the radical treatment of atrial flutter by radiofrequency catheter is achieved in most cases without recurrence, it does not prevent the occurrence of atrial fibrillation that occurs in about 70% of these patients after several years of follow-up. However, the latter arrhythmia is associated with significant morbidity and mortality. The problem of atrial fibrillation occurrence after successful ablation of typical atrial flutter remains physicians primary concern in monitoring these patients.
- Objectives:
The purpose of this study is to demonstrate that the pulmonary veins isolation using balloon cryotherapy technology performed at the time of flutter ablation, significantly reduces the risk of developing atrial fibrillation in the two year period following the procedure.
- Selection Criteria:
Patients referred for ablation of typical atrial flutter with an history of at least one documented episode of atrial fibrillation (atrial flutter remaining the predominant arrhythmia)will be enrolled in the study.
- Study Methods:
This is a prospective, multicenter, randomized, 2-arms study, comparing the rate of atrial fibrillation occurrence over a two years period following either an ablation procedure of typical atrial flutter (Group 1), or a combined procedure of typical atrial flutter ablation and pulmonary veins cryoballoon isolation (Group 2). The enrollment period will be of 18 months.
Randomization will be 1:1 and will be balanced in blocks of varying size. Patients will then be regularly followed up clinically and by long-term ECG recordings.
- Evaluation Criteria:
The primary endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation, documented by an ECG or an R-test, occurring between M3 and M24
-
Number of patients:
170 patients will be enrolled in the study
-
Number of centers:
Four French and three German centers will participate.
- Perspective:
The demonstration of a clinical benefit in terms of atrial fibrillation risk reduction in the patient group with pulmonary vein isolation, could lead to a modification of atrial arrhythmia treatment indication.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Brest, Francie
- CHU de Brest
-
Grenoble, Francie, 38000
- CHU Grenoble
-
La Rochelle, Francie
- CH La Rochelle
-
Marseille, Francie
- AP-HM - Hôpital Nord
-
Marseille, Francie
- Hôpital Privé de Clairval
-
Nantes, Francie
- CHU de Nantes
-
Nantes, Francie
- Nouvelles Cliniques Nantaises
-
Rennes, Francie, 35033
- CHU de Rennes
-
Rouen, Francie, 76000
- University Hospital of Rouen
-
Strasbourg, Francie
- CHU de Strasbourg
-
Toulouse, Francie, 31076
- Clinique Pasteur
-
Tours, Francie
- CHU de Tours
-
Tours, Francie
- Clinique Saint Gatien
-
Trélazé, Francie
- Clinique Saint Joseph
-
Valenciennes, Francie
- Polyclinique Vauban
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
-
Inclusion Criteria:
- Patient with a spontaneous flutter or with a flutter recurrence when it was not considered appropriate to use a preventive treatment so far. The flutter may have been paroxysmal or may still be present.
- Patient with at least one documented episode of typical flutter defined as follows: negative F waves in the inferior territory, positive in V1 and negative in V6 lead, F wave pattern with characteristic "saw tooth" appearance and finally a heart rate comprised between 240 and 320 beats per minute.
- Patient with effective anticoagulant therapy for at least 3 weeks.
- Patient with at least one episode of AF (lasting more than 1 minute) documented on an ECG or a 24 hour Holter recording
- Patient who signed an informed consent.
- Patient with age ≥ 18 yo and ≤ 75 yo
-
Exclusion Criteria:
-
Patients with the following characteristics will be excluded:
- Contraindication to right-heart catheterization
- Contraindication to an anticoagulant treatment
- Patient for which AF is predominant (more recordings of AF than Flutter)
- Persistent AF at the time of inclusion visit
- History of mitral valve surgery
- Known disorders of blood clotting
- Cardiothyreosis
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Life expectancy < 24 months
-
Less than 18 years old and pregnant ladies. As before any ablation, a pregnancy test will be done the day before or the day of the procedure
-
Patient less than 18 years old
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Patient under guardianship
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Patient deprived of their liberty by a court decision
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Atrial flutter ablation
RF atrial flutter ablation |
Radiofrequency ablation of Atrial flutter |
|
Experimentální: Atrial flutter ablation and pulmonary vein isolation
RF Atrial flutter ablation and pulmonary vein isolation using cryoablation |
Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter
Časové okno: an average of 24 months following the ablation procedure
|
Main endpoint will be the recurrence of symptomatic or asymptomatic atrial fibrillation as documented by an ECG or a R-test. Sustained AF episodes of more than a minute will be classified depending if they are symptomatic or not. |
an average of 24 months following the ablation procedure
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Recurrence rate of typical atrial flutter
Časové okno: an average of 24 months following the ablation procedure
|
Recurrence rate of typical atrial flutter |
an average of 24 months following the ablation procedure
|
|
Rate of occurrence of atypical flutter
Časové okno: an average of 24 months following the ablation procedure
|
Occurrence rate of atypical flutter defined as a continuous atrial activity (with no return to the isoelectric line)in at least one lead, whose ECG appearance of F waves is different from that of a typical flutter |
an average of 24 months following the ablation procedure
|
|
Rate of occurrence of atrial tachycardia
Časové okno: an average of 24 months following the ablation procedure
|
Rate of occurrence of atrial tachycardia defined as an atrial activaty that generates a P wave with return to the isoelectric line in all leads |
an average of 24 months following the ablation procedure
|
|
Rate of complications related to the ablation procedure
Časové okno: an average of 3 months after the ablation procedure
|
The following complications will be considered: Hematoma at punction site, Thromboembolic accident, Tamponnade, Phrenic nerve paralysis, Symptomatic stenosis of pulmonary vein, Atrio-ventricular block Atrioesophageal fistula |
an average of 3 months after the ablation procedure
|
|
Rate of major cardiovascular events
Časové okno: an average of 24 months following the ablation procedure
|
Rate of major cardiovascular events such as rehospitalization for arrhythmia, heart failure, or embolic accident |
an average of 24 months following the ablation procedure
|
|
All mortality rate
Časové okno: an average of 24 months following the ablation procedure
|
All mortality rate (including sudden death and any type of death) |
an average of 24 months following the ablation procedure
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Frederic Anselme, MD, University Hospital, Rouen
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhadovaný)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2011/089/HP
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