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

Not Applicable

Recruiting

• Conditions: Ischemic Heart Disease; Ventricular Tachycardia
• Interventions: Other: Adverse events collection; Other: Quality of life questionnaire EQ-5D-5L; Other: Medical-economic evaluation

• Registration Number: NCT06294028
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Study Start: 2024-06-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous catheter ablation	Medical-economic evaluation	Percutaneous catheter ablation
Implantation of an automatic defibrillator	Adverse events collection	Implantation of an automatic defibrillator
Percutaneous catheter ablation	Adverse events collection	Percutaneous catheter ablation
Percutaneous catheter ablation	Quality of life questionnaire EQ-5D-5L	Percutaneous catheter ablation
Implantation of an automatic defibrillator	Quality of life questionnaire EQ-5D-5L	Implantation of an automatic defibrillator
Implantation of an automatic defibrillator	Medical-economic evaluation	Implantation of an automatic defibrillator

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rangueil Hospital; 🇫🇷 Toulouse, France