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

Ischemic Heart Disease Clinical Trial

— VIVA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06294028
• Other study ID #: RC31/21/0338
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: Philippe MAURY, MD
• Phone: 5 61 34 10 18
• Email: maury.p[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 268
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Other:
• Adverse events collection
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
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
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	36 months