Status:
COMPLETED
Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
EIT Health
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tai...
Detailed Description
Ventricular tachycardia ablation is a non-drug alternative for patients with recurrent VT and ischemic cardiomyopathy with a class 1 indication in the latest guidelines. However, it is poorly standard...
Eligibility Criteria
Inclusion
- Age ≥ 18 years,
- Indication for catheter ablation intervention with planned preoperative cardiac CT scan
- Prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non- ischemic cause with documentation of prior ischemic injury),
- Presence of an implantable cardioverter defibrillator, or planned ID implantation before discharge, and
- One of the following monomorphic VT events within last 6 months:
- A: ≥3 episodes of VT treated with antitachycardia pacing (ATP),
- B: ≥1 appropriate ICD shocks,
- C: sustained VT below detection rate of the ICD documented by ECG or any cardiac monitor
- D: Sustained VT recorded on 12 leads ECG in the absence of ICD
- Highly effective contraception for women of childbearing potential, maintained during research procedures
- Signed informed consent ,
- Affiliated to or beneficiary of a health insurance
Exclusion
- Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent,
- Active ischemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug-induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia,
- Are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves,
- Have had a prior catheter ablation procedure for VT,
- Presenting arrhythmia: polymorphic VT or ventricular fibrillation (VF),
- Renal failure (Creatinine clearance \<30 mL/min), have NYHA Functional class IV heart failure, or a systemic illness likely to limit survival to \<1 year,
- Women who are pregnant, lactating, or who are planning to become pregnant during the anticipated study period,
- Patient under legal protection
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT05225935
Start Date
June 29 2022
End Date
December 20 2024
Last Update
June 17 2025
Active Locations (14)
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1
Medical University of Graz
Graz, Austria
2
Public Hospital Elisabethinen Linz
Linz, Austria
3
CHU de Clermont-Ferrand
Clermont-Ferrand, France
4
CHU de Limoges
Limoges, France