Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2025-12-24 @ 10:38 PM
NCT ID:
NCT05225935
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05225935
Study Brief:
Protocol Section:
NCT05225935