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NCT05264831Recruiting

Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure

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

Source: ClinicalTrials.gov · Last updated 24 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
450 (estimated)
First submitted
3 Feb 2022
Start date
20 Feb 2023
Primary completion date
1 Apr 2025
Lead sponsor
Elsan
NCT number
NCT05264831

What you commit to

  • Study type: Interventional
  • Planned participants: 450
  • From 20 Feb 2023 to the primary completion date, 1 Apr 2025
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior atrial fibrillation ablation

Other illness

  • Patient with severe Chronic Obstructive Pulmonary Disease (COPD);
  • Patient with hypertrophic heart disease;
  • Transient Ischemic Attack (TIA) /stroke less than 6 months old;
  • Psychiatric illness affecting follow-up;
  • Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)
  • Cardiac surgery on left atrium
  • Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH)
  • Active cancer
    • Criteria to be validated before randomization, on the day of ablation (these patients cannot be randomized):

Lab values

  • Left Ventricular Ejection Fraction (LVEF) \< 40% ;

Other

  • Criteria to be validated before or after performing electric cardioversion (the study cannot 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 a mechanical or biological mitral valve;
  • Contraindications to anticoagulants;
  • Patients under legal protection
  • Pulmonary embolism or phlebitis less than 6 months old
  • Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients are included in the study registry.
  • Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electric cardioversion attempts: these patients will discontinue from the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Infirmerie Protestante
Coordinator of this site? Confirm its status
Caluire-et-CuireFranceRecruiting
CH Libourne
Coordinator of this site? Confirm its status
LibourneFranceNot yet recruiting
CHU Lille
Coordinator of this site? Confirm its status
LilleFranceActive, not recruiting
Hopital ST Phillbert
Coordinator of this site? Confirm its status
LommeFranceNot yet recruiting
CMC Ambroise Paré Hartmann
Coordinator of this site? Confirm its status
Neuilly-sur-SeineFranceNot yet recruiting
Hôpital Privé Les Franciscaines
Coordinator of this site? Confirm its status
NîmesFranceRecruiting
Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Clinique St Pierre Cardiologie
Coordinator of this site? Confirm its status
PerpignanFranceRecruiting
CHU Rennes
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RennesFranceRecruiting
CCN
Coordinator of this site? Confirm its status
Saint-DenisFranceNot yet recruiting
Clinique Rhéna
Coordinator of this site? Confirm its status
StrasbourgFranceNot yet recruiting
Clinique Pasteur Service de cardiologie/rythmologie
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting
CHU Nancy
Coordinator of this site? Confirm its status
Vandœuvre-lès-NancyFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.