Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure in Patients With Persistent Atrial Fibrillation: a Randomized, Multicentric, and Comparative Study

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ Criteria to be validated for patients included before performing electric cardioversion:

⁃ 1\) Persistent AF (continuous for at least 7 days without interruption according to information transmitted by the cardiologist and the patient), symptomatic and resistant to at 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 resistant to anti-arrhythmic treatment including amiodarone and whom ablative procedure is planned 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 patients may be randomized):

• Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.

Locations
Other Locations
France
Infirmerie Protestante
RECRUITING
Caluire-et-cuire
CH Libourne
NOT_YET_RECRUITING
Libourne
CHU Lille
ACTIVE_NOT_RECRUITING
Lille
Hopital ST Phillbert
NOT_YET_RECRUITING
Lomme
CMC Ambroise Paré Hartmann
NOT_YET_RECRUITING
Neuilly-sur-seine
Hôpital Privé Les Franciscaines
RECRUITING
Nîmes
Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie
RECRUITING
Paris
Clinique St Pierre Cardiologie
RECRUITING
Perpignan
CHU Rennes
RECRUITING
Rennes
CCN
NOT_YET_RECRUITING
Saint-denis
Clinique Rhéna
NOT_YET_RECRUITING
Strasbourg
Clinique Pasteur Service de cardiologie/rythmologie
RECRUITING
Toulouse
Chu Nancy
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Agustín Bortone, MD
agubene@hotmail.com
04 66 26 63 75
Time Frame
Start Date: 2023-02-20
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 450
Treatments
Active_comparator: PVI procedure alone
If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to :~\- Group 1: PVI procedure alone in accordance with ESC recommendations
Experimental: PVI procedure combined with substrate modulation
If the patient presents with AF (= failure of electric cardioversion, approximately 30% of patients), randomization will be carried out according to :~\- Group 2: PVI procedure associated with substrate modulation
Related Therapeutic Areas
Sponsors
Leads: Elsan

This content was sourced from clinicaltrials.gov