Ventricular Catheter Ablation Study (VCAS) (NCT06203262) | Clinical Trial Compass
RecruitingNot Applicable
Ventricular Catheter Ablation Study (VCAS)
Czechia60 participantsStarted 2024-04-12
Plain-language summary
This is a prospective safety and feasibility study to evaluate the safety of the FieldForceâ„¢ Ablation system in patients with ventricular arrhythmia divided into two groups: VT (VCAS-I) and frequent premature ventricular complex (VCAS-II).
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed patient informed consent form (ICF).
✓. Female and male participants between 18 and 80 years.
✓. For VCAS-I group, patients with VT meeting class II-a/b indications in European guideline for catheter ablation, with a clinical VT event detected by an implanted ICD
✓. For VCAS-II group, patients with frequent premature ventricular complexes (PVCs) meeting class II-a/b indications based on European guidelines for catheter ablation.
✓. For VCAS-II, documentation of frequent PVCs by 24 hours Holter with \>15% PVC burden for asymptomatic patients and \>5% PVC burden for symptomatic patients within the last 60 days.
Exclusion criteria
✕. Body Mass Index \> 40.
✕. Pacemaker dependence.
✕. Ineligible for ablation according to Physician judgement (including but not limited to known to have protruding left ventricular thrombus or have implanted mechanical aortic and mitral valves).
✕. Recent MI (less than 90 days) or another reversible cause of VT (e.g., electrolyte abnormalities, drug-induced arrhythmia).
✕. The presence of inferior vena cava embolic protection filter devices.
✕. Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.