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

Toulouse University Hospital

Status: Enrolling

Conditions: Ischemic Heart Disease; Ventricular Tachycardia

Treatments: Other: Quality of life questionnaire EQ-5D-5L; Other: Adverse events collection; Other: Medical-economic evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT06294028

RC31/21/0338

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)
• contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy <1 year, relevant comorbidities)
• pregnancy
• age <18 years
• Patient under legal protection, guardianship or curatorship

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

Implantation of an automatic defibrillator

Active Comparator group

Description:

Implantation of an automatic defibrillator

Treatment:

Other: Medical-economic evaluation

Other: Adverse events collection

Other: Quality of life questionnaire EQ-5D-5L

Percutaneous catheter ablation

Experimental group

Description:

Percutaneous catheter ablation

Treatment:

Other: Medical-economic evaluation

Other: Adverse events collection

Other: Quality of life questionnaire EQ-5D-5L