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

Last updated: April 23, 2024
Sponsor: Elsan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Chest Pain

Arrhythmia

Treatment

Pulmonary Vein Isolation (PVI) alone

PVI procedure associated with substrate modulation

Clinical Study ID

NCT05264831
PACIFIC
2021-A02291-40
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 toinformation transmitted by the cardiologist and the patient), symptomatic and resistant toat 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 resistantto anti-arrhythmic treatment including amiodarone and whom ablative procedure isplanned 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 patientsmay be randomized):
  6. Patient with failed electric cardioversion i.e. in AF, confirmed by ECG.

Exclusion

Exclusion criteria: Criteria to be validated before or after performing electric cardioversion (the studycannot 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 chronicperiodontitis, 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 patientscannot be randomized):
  18. Patient in sinus rhythm 4-6 weeks after electric cardioversion: these patients areincluded in the study registry.
  19. Patient with complete absence of sinus rhythm (less than 10 seconds) after 3 electriccardioversion attempts: these patients will discontinue from the study.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Pulmonary Vein Isolation (PVI) alone
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
October 01, 2027

Study Description

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.

Connect with a study center

  • Infirmerie Protestante

    Caluire Et Cuire, 69300
    France

    Active - Recruiting

  • CH Libourne

    Libourne, 33500
    France

    Site Not Available

  • CHU Lille

    Lille, 59000
    France

    Site Not Available

  • Hopital ST Phillbert

    Lomme, 59462
    France

    Site Not Available

  • CMC Ambroise Paré Hartmann

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Hôpital Privé Les Franciscaines

    Nîmes, 30000
    France

    Active - Recruiting

  • Hôpital Européen Georges Pompidou Service de cardiologie - Unité rythmologie

    Paris, 75015
    France

    Active - Recruiting

  • Clinique St Pierre Cardiologie

    Perpignan, 66000
    France

    Active - Recruiting

  • CHU Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • CCN

    Saint-Denis, 93200
    France

    Site Not Available

  • Clinique Rhéna

    Strasbourg, 67000
    France

    Site Not Available

  • Clinique Pasteur Service de cardiologie/rythmologie

    Toulouse, 31076
    France

    Active - Recruiting

  • Chu Nancy

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

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