Status:
COMPLETED
Cryoballoon Pulmonary Venous Isolation in Patients Referred for Typical Atrial Flutter Ablation
Lead Sponsor:
University Hospital, Rouen
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Flutter
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
\- 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2018
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01521988
Start Date
June 1 2012
End Date
April 1 2018
Last Update
May 29 2018
Active Locations (15)
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1
CHU de Brest
Brest, France
2
CHU Grenoble
Grenoble, France, 38000
3
CH La Rochelle
La Rochelle, France
4
AP-HM - Hôpital Nord
Marseille, France