Ventricular Catheter Ablation Study (VCAS) (NCT06203262) | Clinical Trial Compass
CompletedNot Applicable
Ventricular Catheter Ablation Study (VCAS)
Czechia34 participantsStarted 2024-04-12
Plain-language summary
This is a prospective safety and feasibility study to evaluate the safety of the FieldForce™ 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 range
18 Years – 80 Years
Sex
ALL
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The presence of inferior vena cava embolic protection filter devices.
. Recent cardiac surgery (less than 2 months)
. NYHA Class IV.
. Hemodynamically severe valvular disease that precludes ablation. Severity will be evaluated by using echocardiography, according to AHA and European guidelines.