Kryoballon pulmonal venøs isolation hos patienter henvist til typisk atriel fladderablation (PAF CRIOBLAF)
Forebyggelse af atrieflimren ved kombineret højre isthmus-ablation og cryoballon-pulmonal veneisolation hos patienter med typisk atrieflimren
- 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Brest, Frankrig
- CHU de Brest
-
Grenoble, Frankrig, 38000
- CHU Grenoble
-
La Rochelle, Frankrig
- CH La Rochelle
-
Marseille, Frankrig
- AP-HM - Hôpital Nord
-
Marseille, Frankrig
- Hôpital Privé de Clairval
-
Nantes, Frankrig
- CHU de Nantes
-
Nantes, Frankrig
- Nouvelles Cliniques Nantaises
-
Rennes, Frankrig, 35033
- CHU de Rennes
-
Rouen, Frankrig, 76000
- University Hospital of Rouen
-
Strasbourg, Frankrig
- CHU de Strasbourg
-
Toulouse, Frankrig, 31076
- Clinique Pasteur
-
Tours, Frankrig
- CHU de Tours
-
Tours, Frankrig
- Clinique Saint Gatien
-
Trélazé, Frankrig
- Clinique Saint Joseph
-
Valenciennes, Frankrig
- Polyclinique Vauban
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
-
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
-
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
-
Patient under guardianship
-
Patient deprived of their liberty by a court decision
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Atrial flutter ablation
RF atrial flutter ablation |
Radiofrequency ablation of Atrial flutter |
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence of symptomatic or asymptomatic AF as documented on an ECG or a long term Holter
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recurrence rate of typical atrial flutter
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Frederic Anselme, MD, University Hospital, Rouen
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011/089/HP
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