Actively Recruiting
Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
Led by Elsan · Updated on 2024-04-24
450
Participants Needed
13
Research Sites
240 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims at assessing whether electric cardioversion can act as a discriminant factor between patients requiring Pulmonary Vein Isolation (PVI) procedure alone or PVI procedure combined with substrate modulation. All included patients will undergo an electric cardioversion, then: * Patients with electric cardioversion success will be treated as per Standard of Care and according to ESC recommendations (2020). A prospective registry will be implemented for these patients. * Patients with electric cardioversion failure will be randomized in the study between 2 ablative procedures: * PVI procedure alone * PVI procedure combined with substrate modulation
CONDITIONS
Official Title
Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persistent atrial fibrillation lasting at least 7 days, symptomatic and resistant to at least one anti-arrhythmic drug including amiodarone
- Treated by electric cardioversion for persistent atrial fibrillation with planned ablation within 4-6 weeks after cardioversion
- Life expectancy greater than 5 years
- Aged between 18 and 80 years at the time of electric cardioversion
- Affiliation to a health insurance system
- Informed about the study and signed informed consent
- Failed electric cardioversion confirmed by ECG prior to randomization on the day of ablation
You will not qualify if you...
- Current hyperthyroidism
- Pregnant or breastfeeding women
- Body Mass Index (BMI) greater than 35
- Severe chronic obstructive pulmonary disease (COPD)
- Hypertrophic heart disease
- Mechanical or biological mitral valve
- Contraindications to anticoagulants
- Transient ischemic attack (TIA) or stroke less than 6 months old
- Psychiatric illness affecting follow-up
- Left ventricular ejection fraction (LVEF) less than 40%
- Uncontrolled ischemic heart disease (angina, myocardial ischemia)
- Under legal protection
- Prior cardiac surgery on left atrium
- Active inflammatory conditions (cancer, rheumatoid arthritis, acute or chronic periodontitis, Crohn's disease, ulcerative colitis)
- Pulmonary embolism or phlebitis less than 6 months old
- Prior atrial fibrillation ablation
- Active cancer
- Patient in sinus rhythm 4-6 weeks after electric cardioversion (not randomized, included in registry)
- Complete absence of sinus rhythm after 3 electric cardioversion attempts (discontinued from study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Infirmerie Protestante
Caluire-et-Cuire, France, 69300
Actively Recruiting
2
CH Libourne
Libourne, France, 33500
Not Yet Recruiting
3
CHU Lille
Lille, France, 59000
Active, Not Recruiting
4
Hopital ST Phillbert
Lomme, France, 59462
Not Yet Recruiting
5
CMC Ambroise Paré Hartmann
Neuilly-sur-Seine, France, 92200
Not Yet Recruiting
6
Hôpital Privé Les Franciscaines
Nîmes, France, 30000
Actively Recruiting
7
Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie
Paris, France, 75015
Actively Recruiting
8
Clinique St Pierre Cardiologie
Perpignan, France, 66000
Actively Recruiting
9
CHU Rennes
Rennes, France, 35033
Actively Recruiting
10
CCN
Saint-Denis, France, 93200
Not Yet Recruiting
11
Clinique Rhéna
Strasbourg, France, 67000
Not Yet Recruiting
12
Clinique Pasteur Service de cardiologie/rythmologie
Toulouse, France, 31076
Actively Recruiting
13
Chu Nancy
Vandœuvre-lès-Nancy, France, 54500
Not Yet Recruiting
Research Team
A
Agustín Bortone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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