Pulsed Field Ablation for Ventricular Arrhythmias (NCT07727330) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulsed Field Ablation for Ventricular Arrhythmias
30 participantsStarted 2026-07
Plain-language summary
This is a prospective, single-center, single-arm exploratory clinical study designed to evaluate the efficacy and safety of pulsed field ablation for the treatment of ventricular arrhythmias.
Approximately 30 patients with ventricular arrhythmias who have an indication for catheter ablation and are scheduled to undergo pulsed field ablation will be enrolled. Eligible participants may include patients with frequent premature ventricular contractions, sustained monomorphic ventricular tachycardia, or a history of malignant ventricular arrhythmias with an indication for catheter ablation.
All participants will undergo pulsed field ablation using a disposable magnetic navigation and contact force-sensing pulsed field ablation catheter. The study will assess immediate procedural success, treatment success at 6 months after ablation, procedural characteristics, quality of life, and adverse events or serious adverse events during the study period.
Who can participate
Age range
18 Years – 75 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
. Age 18 to 75 years, inclusive.
. Diagnosis of ventricular arrhythmia with an indication for catheter ablation, and scheduled to undergo pulsed field ablation, meeting one of the following conditions:
. Frequent premature ventricular contractions, defined as a premature ventricular contraction burden greater than 10% of total heartbeats on 24-hour Holter monitoring;
. Sustained monomorphic ventricular tachycardia;
. History of malignant ventricular arrhythmias, including sustained polymorphic ventricular tachycardia, ventricular flutter, or ventricular fibrillation, with an indication for catheter ablation.
. For participants with an indication for implantable cardioverter-defibrillator implantation, the participant has already received an implantable cardioverter-defibrillator or agrees to undergo implantable cardioverter-defibrillator implantation in the near future.
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.
What they're measuring
1
Immediate Procedural Success Rate
Timeframe: At the end of the ablation procedure, after a 30-minute post-ablation observation period
. Able and willing to provide written informed consent and comply with all study follow-up requirements.
Exclusion criteria
. Presence of atrial arrhythmias before the procedure that cannot be treated using the study device.
. Ventricular arrhythmias caused by electrolyte disturbance, reversible causes, or non-cardiac causes.
. Severe left ventricular enlargement, defined as left ventricular anteroposterior diameter greater than 80 mm.
. Left ventricular ejection fraction of 35% or less.
. New York Heart Association functional class III or IV.
. Previous cardiac surgery, including patent foramen ovale closure, left atrial appendage closure, cardiac valve repair or replacement, or other cardiac surgery that makes the participant unsuitable for catheter ablation.
. Significant congenital cardiac anatomical abnormalities that prevent the ablation catheter from accessing the target ablation area.
. Planned cardiac surgery or other major surgery within the next 12 months that may affect ablation treatment, including heart transplantation, left atrial appendage closure, or patent foramen ovale closure.