International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital, Toulouse

About this trial

Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.

On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.

Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ischemic heart disease with history of infarction - LVEF> 35% (measured by MRI)

sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -

having signed informed consent

affiliated to a social security system

Disqualifiers

transient regressive cause of ventricular tachycardia

recent myocardial infarction (<2 months)

ventricular tachycardia by reentry from branch to branch

serious conduction disturbances (with indication of stimulation)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adverse events collection

    Other intervention

    Collection of deaths from any cause, hospitalizations or emergency consultations for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)

  • Quality of life questionnaire EQ-5D-5L

    Other intervention

    Questionnaire on the patient's quality of life and health in 6 questions: on mobility, the person's autonomy, current activities, pain, anxiety. Answers range from "no problem" to "unable" and 5 possible answers to each question. The last question concerns the patient's health, the patient must rate his or her health on a scale of 0 to 100

  • Medical-economic evaluation

    Other intervention

    Collection of expenses incurred by the care of patients in each arm will be collected over a period of 36 months. Direct medical and non-medical costs as well as costs related to absences from the workplace will be included in the analysis. Healthcare consumption will be collected using the National Health Data System (SNDS).

Treatment groups

268 Participants
are divided into 2 treatment groups
Group A: Implantation of an automatic defibrillatorActive comparator 3 interventions
Group B: Percutaneous catheter ablationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Monitoring for the occurrence of at least one serious event during the 36 months of follow-up

Monitoring of the occurrence of death from any cause, hospitalization or emergency consultation for any event related to ventricular arrhythmia or its treatment (recurrence of ventricular tachycardia or complication linked to the defibrillator or crossover from one group to another)

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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