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

NCT06294028 | Recruiting

• 1 other identifier: RC31/21/0338
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Ventricular Tachycardia

Keywords

Ablation

Outcome Measures

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)

  36 months

Study Arms (2)

Implantation of an automatic defibrillator

ACTIVE COMPARATOR

Implantation of an automatic defibrillator

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

Percutaneous catheter ablation

EXPERIMENTAL

Percutaneous catheter ablation

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

Interventions

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)

Implantation of an automatic defibrillator; Percutaneous catheter ablation

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

Implantation of an automatic defibrillator; Percutaneous catheter ablation

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).

Implantation of an automatic defibrillator; Percutaneous catheter ablation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Rangueil Hospital

Toulouse, France, 31059, France

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe MAURY, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe MAURY, MD

CONTACT

5 61 34 10 18; maury.p@chu-toulouse.fr

Audrey TOMASIK

CONTACT

5 61 77 85 97; tomasik.a@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)