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NCT Number: NCT06294028

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

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.

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Key information

Conditions

Ischemic Heart Disease Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Vascular Diseases Ventricular Tachycardia

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rangueil Hospital

Toulouse, France, 31059

Location status: Recruiting

Location contact

Philippe MD MAURY

CONTACT

[email protected]

561341018 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adverse events collection

Other

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

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

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).

Primary outcomes

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Audrey TOMASIK

CONTACT

[email protected]

5 61 77 85 97 ext. +33

Philippe MAURY, MD

CONTACT

[email protected]

5 61 34 10 18 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: VIVA

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 5, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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