Pulsed Field Ablation for Ventricular Arrhythmias
ConditionVentricular Arrhythmias
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXi'an Jiaotong University
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 to 75 years, inclusive.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pulsed Field Ablation
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov