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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Pulsed Field Ablation
Procedure/SurgeryPulsed field ablation will be performed in patients with ventricular arrhythmias using a disposable magnetic navigation and contact force-sensing pulsed field ablation catheter. The ablation target site, ablation strategy, and procedural endpoint will be determined by the investigator according to the type and origin of the ventricular arrhythmia, electroanatomical mapping findings, and standard clinical practice.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Pulsed Field AblationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Immediate Procedural Success Rate
Immediate procedural success is defined as meeting either of the following criteria after ablation: (1) disappearance of the clinical ventricular arrhythmia, with no reinduction by pharmacological provocation and/or programmed electrical stimulation after a 30-minute observation period; or (2) a reduction of at least 80% in the number or duration of abnormal ventricular beats compared with the pre-ablation baseline, maintained during the 30-minute observation period and after pharmacological provocation and/or programmed electrical stimulation.
Time frame
At the end of the ablation procedure, after a 30-minute post-ablation observation period2
Treatment Success Rate at 6 Months After Ablation
Treatment success at 6 months after ablation is defined as disappearance of the clinical ventricular arrhythmia on follow-up Holter monitoring; or at least an 80% reduction in the number or duration of abnormal ventricular beats compared with baseline Holter monitoring. The assessment will be based on clinical follow-up, standard electrocardiography, Holter monitoring, device interrogation when applicable, and investigator assessment.
Time frame
6 months after ablationSecondary outcomes
1
Total Procedure Time
The total duration of the ablation procedure, as recorded in the procedural record, will be reported in minutes.
Time frame
During the ablation procedure2
Total Pulsed Field Ablation Delivery Time
The cumulative duration of pulsed field energy delivery during the ablation procedure will be recorded and reported in seconds.
Time frame
During the ablation procedure3
Number of Pulsed Field Ablation Applications
The total number of pulsed field ablation applications delivered during the ablation procedure will be recorded for each participant.
Time frame
During the ablation procedure4
Percentage of Participants With Death, Stroke, or Transient Ischemic Attack
The percentage of participants who experience at least one of the following events will be reported: all-cause death, stroke, or transient ischemic attack.
Time frame
From enrollment through 6 months after ablationOther outcomes
1
Distribution of Pulsed Field Ablation Sites
The anatomical sites at which pulsed field ablation is performed will be recorded and summarized as the number and percentage of participants receiving ablation at each anatomical location.
Time frame
During the ablation procedure2
Percentage of Participants Requiring Rescue Radiofrequency Ablation
Rescue radiofrequency ablation is defined as additional radiofrequency energy delivery when the predefined procedural endpoint is not achieved after pulsed field ablation. The percentage of participants requiring rescue radiofrequency ablation will be reported.
Time frame
During the ablation procedure3
Percentage of Participants With Adverse Events
The percentage of participants who experience at least one adverse event during the study period will be reported.
Time frame
From enrollment through 6 months after ablationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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