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
- Diseases
- Atrial fibrillation
- 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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Infirmerie Protestante Coordinator of this site? Confirm its status | Caluire-et-Cuire | France | Recruiting |
| CH Libourne Coordinator of this site? Confirm its status | Libourne | France | Not yet recruiting |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Hopital ST Phillbert Coordinator of this site? Confirm its status | Lomme | France | Not yet recruiting |
| CMC Ambroise Paré Hartmann Coordinator of this site? Confirm its status | Neuilly-sur-Seine | France | Not yet recruiting |
| Hôpital Privé Les Franciscaines Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Clinique St Pierre Cardiologie Coordinator of this site? Confirm its status | Perpignan | France | Recruiting |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| CCN Coordinator of this site? Confirm its status | Saint-Denis | France | Not yet recruiting |
| Clinique Rhéna Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
| Clinique Pasteur Service de cardiologie/rythmologie Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU Nancy Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.