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New treatment option for Persistent Atrial Fibrillation
Official title Pulmonary Vein Isolation Alone or in Combination With Substrate Modulation After Electric Cardioversion Failure
ClinicalTrials.gov ID: NCT05264831
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Criteria to be validated for patients included before performing electric cardioversion: 1) Persistent AF (continuous for at least 7 days without...
- Patient treated by electric cardioversion for persistent AF, symptomatic and resistant to anti-arrhythmic treatment including amiodarone and whom...
- 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;
You likely can't join if
- 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 severe Chronic Obstructive Pulmonary Disease (COPD);
- Patient with hypertrophic heart disease;
See the full eligibility criteria
- 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...
- 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...
- 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 assigned by chance):
- Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.
- 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 severe Chronic Obstructive Pulmonary Disease (COPD);
- Patient with hypertrophic heart disease;
- Patient with a mechanical or biological mitral valve;
- Contraindications to anticoagulants;
- Transient Ischemic Attack (TIA) /stroke less than 6 months old;
- Psychiatric illness affecting follow-up;
- Left Ventricular Ejection Fraction (LVEF) \< 40% ;
- Uncontrolled ischaemic heart disease (angina, myocardial ischaemia)
- Patients under legal protection
- Cardiac surgery on left atrium
- Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH)
- Pulmonary embolism or phlebitis less than 6 months old
- Prior atrial fibrillation ablation
- Active cancer Criteria to be validated before randomization, on the day of ablation (these patients cannot be assigned by chance):
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Caluire-et-Cuire, France
- Libourne, France
- Lille, France
- Lomme, France
- Neuilly-sur-Seine, France
- Nîmes, France
- Paris, France
- Perpignan, France
- Rennes, France
- Saint-Denis, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caluire-et-Cuire, France; Libourne, France; Lille, France; Lomme, France; Neuilly-sur-Seine, France; Nîmes, France and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.