Status:
ACTIVE_NOT_RECRUITING
Marshall Ethanolization, Pulmonary Vein Isolation and Line Completion for Ablation of Persistent Atrial Fibrillation
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In ablation strategy for persistent Atrial Fibrillation (PsAF), ablation limited to Pulmonary Vein (PV) isolation is the most straightforward approach but the result give only 50% of arrhythmia free f...
Detailed Description
Atrial fibrillation (AF) characterized by a fast and anarchic electrical activation of the atria, results in uncoordinated and inefficient atrial contractions that increases the risks of heart failure...
Eligibility Criteria
Inclusion
- Age \> 18 years of both genders
- Suitable candidate for catheter and ablation of atrial fibrillation defined as: history of symptomatic persistent atrial fibrillation in the past year documented by ECG,
- Patient affiliated or beneficiary of social security scheme,
- Free, informed and written consent signed by the participant and the principal investigator (at least at the inclusion date and before all exams required for the clinical research),
- Effective contraception for women of childbearing potential.
Exclusion
- Prior left atrial heart ablation procedure,
- Documented left atrial thrombus or another abnormality which precludes catheter introduction,
- Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant (NOAC)),
- Contraindication to iodinated contrast products (history of major immediate reaction, thyrotoxicosis),
- Ethanol hypersensitivity,
- Unstable angina or ongoing myocardial ischemia,
- Myocardial infarction within 3 months prior to inclusion,
- Congenital heart disease, where the underlying abnormality increases the ablation risk,
- Severe bleeding, clotting or thrombotic disorder,
- Hypertrophic cardiomyopathy defined by a left ventricular septum thickness \> 1.5 cm,
- Pregnant, parturient or nursing women,
- Person unable to give informed consent,
- Patient detained by judicial or administrative order, patient under legal protection (guardianship, curators, safeguarding justice).
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2027
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT04681872
Start Date
September 20 2021
End Date
September 20 2027
Last Update
July 1 2025
Active Locations (9)
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1
AZ Sint Jan Brugge
Bruges, Belgium, 8000
2
Clinique Saint Augustin
Bordeaux, France, 33074
3
Clermont-Ferrand University Hospital
Clermont-Ferrand, France, 63003
4
Ambroise Paré Hospital
Neuilly-sur-Seine, France, 92200