Phase
Condition
Dysrhythmia
Chest Pain
Arrhythmia
Treatment
Pulmonary Vein Isolation (PVI) alone
PVI procedure associated with substrate modulation
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria: Criteria to be validated for patients included before performing electric cardioversion:
- Persistent AF (continuous for at least 7 days without interruption according toinformation transmitted by the cardiologist and the patient), symptomatic and resistant toat leat one anti-arrhythmic drug treatment including amiodarone; Criteria to be validated for patients included after performing electric cardioversion :
- Patient treated by electric cardioversion for persistent AF, symptomatic and resistantto anti-arrhythmic treatment including amiodarone and whom ablative procedure isplanned in the following 4-6 weeks after electric cardioversion Criteria to be validated for all patients included:
- Life expectancy > 5 years;
- Female or male between 18 and 80 years of age at the electric cardioversion time
- Affiliation to a health insurance system;
- Patient informed of the study and having signed informed consent Criteria to be validated prior to randomization on the day of ablation (these patientsmay be randomized):
- Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.
Exclusion
Exclusion criteria: Criteria to be validated before or after performing electric cardioversion (the studycannot be proposed to patients corresponding to these criteria):
- Current hyperthyroidism;
- Pregnant or breastfeeding woman;
- Patient with a Body Mass Index (BMI) greater than 35;
- Patient with severe Chronic Obstructive Pulmonary Disease (COPD);
- Patient with hypertrophic heart disease;
- Patient with a mechanical or biological mitral valve;
- Contraindications to anticoagulants;
- Transient Ischemic Attack (TIA) /stroke less than 6 months old;
- Psychiatric illness affecting follow-up;
- Left Ventricular Ejection Fraction (LVEF) < 40% ;
- Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)
- Patients under legal protection
- Cardiac surgery on left atrium
- Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronicperiodontitis, Crohn's disease, RCUH)
- Pulmonary embolism or phlebitis less than 6 months old
- Prior atrial fibrillation ablation
- Active cancer Criteria to be validated before randomization, on the day of ablation (these patientscannot be randomized):
- Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients areincluded in the study registry.
- Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electriccardioversion attempts: these patients will discontinue from the study.
Study Design
Study Description
Connect with a study center
Infirmerie Protestante
Caluire Et Cuire, 69300
FranceActive - Recruiting
CH Libourne
Libourne, 33500
FranceSite Not Available
CHU Lille
Lille, 59000
FranceSite Not Available
Hopital ST Phillbert
Lomme, 59462
FranceSite Not Available
CMC Ambroise Paré Hartmann
Neuilly-sur-Seine, 92200
FranceSite Not Available
Hôpital Privé Les Franciscaines
Nîmes, 30000
FranceActive - Recruiting
Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie
Paris, 75015
FranceActive - Recruiting
Clinique St Pierre Cardiologie
Perpignan, 66000
FranceActive - Recruiting
CHU Rennes
Rennes, 35033
FranceActive - Recruiting
CCN
Saint-Denis, 93200
FranceSite Not Available
Clinique Rhéna
Strasbourg, 67000
FranceSite Not Available
Clinique Pasteur Service de cardiologie/rythmologie
Toulouse, 31076
FranceActive - Recruiting
Chu Nancy
Vandœuvre-lès-Nancy, 54500
FranceSite Not Available
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