Pulsed Field Ablation for Ventricular Arrhythmias

NCT07727330 | Not Yet Recruiting

• 1 other identifier: 2025-100-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventricular Arrhythmias

Keywords

Ventricular arrhythmias

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months after ablation

Secondary Outcomes (8)

• Total Procedure Time

  During the ablation procedure

• Total Pulsed Field Ablation Delivery Time

  During the ablation procedure

• Number of Pulsed Field Ablation Applications

  During the ablation procedure

• Percentage of Participants With Death, Stroke, or Transient Ischemic Attack

  From enrollment through 6 months after ablation

• Percentage of Participants With Procedure-Related Complications

  From the ablation procedure through 6 months after ablation

Other Outcomes (3)

• Distribution of Pulsed Field Ablation Sites

  During the ablation procedure

• Percentage of Participants Requiring Rescue Radiofrequency Ablation

  During the ablation procedure

• Percentage of Participants With Adverse Events

  From enrollment through 6 months after ablation

Study Arms (1)

Pulsed Field Ablation

EXPERIMENTAL

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

Interventions

Pulsed Field Ablation PROCEDURE

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.

Pulsed Field Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following 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.
• Able and willing to provide written informed consent and comply with all study follow-up requirements.

You may not qualify if:

• 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.
• Intracardiac thrombus, myxoma, occlusion device, or other condition that may interfere with catheter insertion or manipulation.
• Severe vascular access obstruction, such as an implanted inferior vena cava filter or mural thrombus.
• Uncontrolled hypertension, defined as persistent systolic blood pressure of 180 mmHg or higher or persistent diastolic blood pressure of 110 mmHg or higher.
• Severe restrictive or obstructive pulmonary disease or chronic respiratory disease that, in the investigator's judgment, makes the participant unsuitable for cardiac intervention.
• Obvious bleeding tendency or hematologic disease.
• Untreated or uncontrolled hyperthyroidism or hypothyroidism.
• Acute or severe systemic active infection, significant hepatic or renal dysfunction defined as ALT, AST, or creatinine greater than twice the upper limit of normal, malignancy, or end-stage disease.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Central Study Contacts

Hongtao Wang

CONTACT

+86 13891944803; Wht506@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share