An interventional study of Pulsed Field Ablation in Ventricular Arrhythmias, sponsored by Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
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.
Ventricular arrhythmias include frequent premature ventricular contractions, sustained ventricular tachycardia, ventricular flutter, and ventricular fibrillation. Catheter ablation is an important treatment option for selected patients with ventricular arrhythmias. Pulsed field ablation is a non-thermal ablation technology that may achieve myocardial tissue ablation through irreversible electroporation and may reduce thermal injury to surrounding tissues.
This study is a prospective, single-center, single-arm exploratory clinical study. Approximately 30 patients with ventricular arrhythmias who have an indication for catheter ablation and are scheduled to undergo pulsed field ablation will be enrolled. The study aims to preliminarily evaluate the acute and 6-month effectiveness of pulsed field ablation, as well as its procedural safety profile.
The investigational procedure will be performed 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.
The primary outcomes are immediate procedural success and treatment success at 6 months after ablation. Immediate procedural success will be assessed at the end of the ablation procedure. Treatment success at 6 months will be evaluated through clinical follow-up, standard electrocardiography, Holter monitoring, device interrogation when applicable, and investigator assessment.
Secondary outcomes include procedure time, pulsed field ablation delivery time and number of applications, ablation site information, fluoroscopy time, quality of life assessed using EQ-5D-5L and SF-36, death, stroke or transient ischemic attack, procedure-related complications, pulsed field energy-related complications, and other adverse events or serious adverse events during the study period.
As an exploratory study, this trial is intended to provide preliminary clinical evidence regarding the feasibility, efficacy, and safety of pulsed field ablation for ventricular arrhythmias and to support the design of future larger-scale studies.
Xi'an Jiaotong University is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Diagnosis of ventricular arrhythmia with an indication for catheter ablation, and scheduled to undergo pulsed field ablation, meeting one of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with ventricular arrhythmias who meet the eligibility criteria will undergo pulsed field ablation 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.
Procedure: Pulsed Field Ablation
Pulsed 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.
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 period
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 ablation
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 procedure
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 procedure
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 procedure
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 ablation
Percentage of Participants With Procedure-Related Complications
The percentage of participants who experience at least one procedure-related complication will be reported. Procedure-related complications include vascular access complications, such as pseudoaneurysm and arteriovenous fistula; cardiac perforation or cardiac tamponade; myocardial infarction; pericarditis; and other complications considered related to the ablation procedure.
Time frame: From the ablation procedure through 6 months after ablation
Percentage of Participants With Pulsed Field Ablation-Related Complications
The percentage of participants who experience at least one complication considered related to pulsed field ablation will be reported. Events of interest include phrenic nerve injury, coronary artery spasm, acute kidney injury, and other complications considered related to pulsed field energy delivery.
Time frame: From the ablation procedure through 6 months after ablation
Change From Baseline in EQ-5D-5L Index Score
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. Responses will be converted to an EQ-5D-5L index score using an appropriate value set. Higher scores indicate better health status. Changes from baseline at 3 and 6 months after ablation will be reported.
Time frame: Baseline, 3 months, and 6 months after ablation
Change From Baseline in SF-36 Score
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Changes from baseline in SF-36 scores will be evaluated at 3 and 6 months after ablation. Higher scores indicate better health-related quality of life.
Time frame: Baseline, 3 months, and 6 months after ablation
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 procedure
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 procedure
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 ablation
Plan to share: No — Individual participant data will not be shared with researchers outside the study team due to participant privacy, data protection requirements, and the exploratory nature of this single-center study.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Xi'an Jiaotong University