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

Elsan450 enrolled

Overview

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

Atrial fibrillation (AF) is the most common heart rhythm disorder. It is the result of uncoordinated action of the atrial myocardial cells, causing rapid and irregular contraction of the heart's atria. The AF prevalence in adults is currently estimated to be between 2% and 4% and is expected to increase by a factor of 2.3 in the next few years, due to the increased longevity of the general population and the increased search for undiagnosed AF. Increased age is an important risk factor for AF, but other increased comorbidities, including hypertension, diabetes, heart failure, coronary artery disease, chronic renal failure, obesity, and obstructive sleep apnoea syndrome, are also important; modifiable risk factors contribute strongly to the development and progression of AF (ESC Guideline, 2020). The European Society of Cardiology (ESC) recommended pulmonary vein isolation (PVI) (Class IA) as first-line ablative strategy for persistent AF (Class IA) (ESC Guideline, 2020). However, PVI alone is only effective in treating about 40% to 60% of patients with persistent AF in the general population (unselected). If we apply this strategy to all patients (PVI alone), we accept to re-do ablative procedure in up to 60% of patients. The second feasible strategy is to treat patients with persistent AF by PVI combined with substrate modulation (ESC Class IIb). This strategy, when done well, by creating irreversible lesions (Marshall-PLAN) can effectively treat 70% to 80% of AF patients. But this implies that the investigator will be doing unnecessary substrate modulation in up to 40% of patients, which can lead to increased risks associated with the ablative procedure, longer procedure times, multiple lesions, etc… In addition, incorrect or incomplete substrate modulation is pro-arrhythmic and leads to recurrences in the form of left atrial flutters, tolerance of which, is generally poor. Both ablative strategies have been widely validated in large numbers of published studies. The problem is to know when and for which patients to apply one or the other of the two strategies. Electric cardioversion could help in selecting the most appropriate strategy.

Interventions

Pulmonary Vein Isolation (PVI) alonePROCEDURE

PVI procedures correspond to point-by-point 50W AI-guided RF applications (400 posterior LA wall, and 550 elsewhere). The PVI will be validated by the absence of any activity recorded inside the PV encirclement by a multipolar catheter (either a Lasso catheter or a Pentaray catheter) (entrance block) and by the non-capture of the LA despite pacing maneuvers from inside the encirclement (exit block). The bidirectional block will be validated again after a 15-minutes waiting period.

PVI procedure associated with substrate modulationPROCEDURE

PVI procedure associated with substrate modulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion 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 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 : 1. 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: 2. Life expectancy \> 5 years; 3. Female or male between 18 and 80 years of age at the electric cardioversion time 4. Affiliation to a health insurance system; 5. 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): 6. Patient with failed electric cardioversion i.e. in AF, confirmed by ECG. Exclusion criteria: Criteria to be validated before or after performing electric cardioversion (the study cannot be proposed to patients corresponding to these criteria): 1. Current hyperthyroidism; 2. Pregnant or breastfeeding woman; 3. Patient with a Body Mass Index (BMI) greater than 35; 4. Patient with severe Chronic Obstructive Pulmonary Disease (COPD); 5. Patient with hypertrophic heart disease; 6. Patient with a mechanical or biological mitral valve; 7. Contraindications to anticoagulants; 8. Transient Ischemic Attack (TIA) /stroke less than 6 months old; 9. Psychiatric illness affecting follow-up; 10. Left Ventricular Ejection Fraction (LVEF) \< 40% ; 11. Uncontrolled ischaemic heart disease (angina, myocardial ischaemia) 12. Patients under legal protection 13. Cardiac surgery on left atrium 14. Inflammatory status in progress (cancer, rheumatoid arthritis, PPRZ, acute or chronic periodontitis, Crohn's disease, RCUH) 15. Pulmonary embolism or phlebitis less than 6 months old 16. Prior atrial fibrillation ablation 17. Active cancer Criteria to be validated before randomization, on the day of ablation (these patients cannot be randomized): 18. Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients are included in the study registry. 19. Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electric cardioversion attempts: these patients will discontinue from the study.

Locations (13)

Infirmerie Protestante

Caluire-et-Cuire, France

RECRUITING

CH Libourne

Libourne, France

NOT_YET_RECRUITING

CHU Lille

Lille, France

ACTIVE_NOT_RECRUITING

Hopital ST Phillbert

Lomme, France

NOT_YET_RECRUITING

CMC Ambroise Paré Hartmann

Neuilly-sur-Seine, France

NOT_YET_RECRUITING

Hôpital Privé Les Franciscaines

Nîmes, France

RECRUITING

Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie

Paris, France

RECRUITING

Clinique St Pierre Cardiologie

Perpignan, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CCN

Saint-Denis, France

NOT_YET_RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

1-year sinus rhythm maintenance rate

Rate of patients with sinus rhythm (yes/no) at 1 year after a single ablative procedure

Time frame: At 1 year after ablation

Secondary Outcomes

Rate of patients with sinus rhythm (randomized patients)

Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.

Time frame: At 1 year after ablation

Rate of patients with sinus rhythm (registry patients)

Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.

Time frame: At 1 year after ablation

Rate of patients with sinus rhythm (randomized and registry patients, strategy PVI procedure alone)

Rate of patients with sinus rhythm during 1 year after ablation and after a single ablative procedure.

Time frame: At 1 year after ablation

Duration (in minutes) of ablative procedure

Time frame: On the day of the ablative procedure

Duration (in minutes) of radiofrequency use

Time frame: On the day of the ablative procedure

Duration (in minutes) of Fluoroscopy

Time frame: On the day of the ablative procedure

Duration (in days) of hospitalization

Time frame: From date of surgery until the date of discharge from hospital assessed up to 1 day

Evaluation of major complications rate

Tamponade and/or stroke rate out of the blanking period and up to 1-year follow-up

Time frame: Up to 1 year

Evaluation of drug treatment use rate or electric cardioversion in the blanking period

Number of patients using drug treatment and/or electric cardioversion during the blanking period (first 3 months after ablation) between the two strategies (randomized patients)

Time frame: At three months after ablation

Evaluation of the minor complications rate between the two strategies after 1-year follow-up (randomized patients)

Occurrence of a false aneurysm or fistulas at the puncture sites and/or occurrence of a post-ablation pericardial reaction

Time frame: up to 1-year follow-up

Evaluation of the vein isolation as well as other linear lesions in patients with recurrence of atrial fibrillation during 1 year after ablation

Pulmonary vein isolation as well as other linear lesions block assessment during redo procedures

Time frame: up to 1-year follow-up

Evaluation of the impact of low voltage areas on the response to EC prior to catheter ablation

Relationship between the presence or absence of LA low voltage areas and the response to EC prior to catheter ablation Relationship between the extent of LA low voltage areas and the response to EC prior to catheter ablation Relationship between the location of LA low voltage areas and the response to EC prior to catheter ablation

Time frame: catheter ablation

Evaluation of the impact of low voltage areas on the success of the ablation procedure

Relationship between the presence or absence of LA low voltage areas and the success of the ablation procedure Relationship between the extent of LA low voltage areas and the success of the ablation procedure Relationship between the location of LA low voltage areas and the success of the ablation procedure

Time frame: ablation procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (13)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts