Ischemic Heart DiseaseVIVANCT06294028
International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease With Minimally Impaired Ejection Fraction
A study testing Adverse events collection, Quality of life questionnaire EQ-5D-5L and Medical-economic evaluation in people with Ischemic Heart Disease and Ventricular Tachycardia, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Heart Disease, Ventricular Tachycardia
- What is being tested?
- Adverse events collection, Quality of life questionnaire EQ-5D-5L and Medical-economic evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rangueil Hospital
Toulouse, France, 31059
Philippe MD MAURY, 561341018 ext. +33, maury.p@chu-touloue.fr
About this study
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
- Being tested
- Adverse events collection, Quality of life questionnaire EQ-5D-5L, Medical-economic evaluation
- Keywords
- Ablation
- Medical subject headings
- Myocardial Ischemia, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse events collectionOther
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-5LOther
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 evaluationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Implantation of an automatic defibrillator | Active comparator | Implantation of an automatic defibrillator Receives: Other: Adverse events collection; Other: Quality of life questionnaire EQ-5D-5L; Other: Medical-economic evaluation |
| Percutaneous catheter ablation | Experimental | Percutaneous catheter ablation Receives: Other: Adverse events collection; Other: Quality of life questionnaire EQ-5D-5L; Other: Medical-economic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start12 Jun 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MAURY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294028
- Sponsor's protocol ID
- RC31/21/0338
- Acronym
- VIVA
- Status last verified
- May 2026
- First submitted
- 27 Feb 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06294028
- Acronym / sponsor ID
- VIVA / RC31/21/0338
- Conditions
- Ischemic Heart Disease, Ventricular Tachycardia
- Keywords
- Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implantation of an automatic defibrillator | Active comparator | Other: Adverse events collection, Other: Quality of life questionnaire EQ-5D-5L, Other: Medical-economic evaluationImplantation of an automatic defibrillator |
| Percutaneous catheter ablation | Experimental | Other: Adverse events collection, Other: Quality of life questionnaire EQ-5D-5L, Other: Medical-economic evaluationPercutaneous catheter ablation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adverse events collectionCollection 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) | Other | Implantation of an automatic defibrillator, Percutaneous catheter ablation |
| Quality of life questionnaire EQ-5D-5LQuestionnaire 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 | Other | Implantation of an automatic defibrillator, Percutaneous catheter ablation |
| Medical-economic evaluationCollection 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). | Other | Implantation of an automatic defibrillator, Percutaneous catheter ablation |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Ischemic Heart Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philippe MAURY, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adverse events collection, Quality of life questionnaire EQ-5D-5L and Medical-economic evaluation in people with Ischemic Heart Disease and Ventricular Tachycardia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe MAURY, MD (5 61 34 10 18 ext. +33, maury.p@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring for the occurrence of at least one serious event during the 36 months of follow-up (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.