Ventricular Arrhythmias
Conditions
Keywords
Ventricular arrhythmias
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.
Detailed description
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.
Interventions
PROCEDUREPulsed 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.
Sponsors
Xi'an Jiaotong University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria: 1. Age 18 to 75 years, inclusive. 2. Diagnosis of ventricular arrhythmia with an indication for catheter ablation, and scheduled to undergo pulsed field ablation, meeting one of the following conditions: 1. Frequent premature ventricular contractions, defined as a premature ventricular contraction burden greater than 10% of total heartbeats on 24-hour Holter monitoring; 2. Sustained monomorphic ventricular tachycardia; 3. History of malignant ventricular arrhythmias, including sustained polymorphic ventricular tachycardia, ventricular flutter, or ventricular fibrillation, with an indication for catheter ablation. 3. 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. 4. Able and willing to provide written informed consent and comply with all study follow-up requirements.
Exclusion criteria
1. Presence of atrial arrhythmias before the procedure that cannot be treated using the study device. 2. Ventricular arrhythmias caused by electrolyte disturbance, reversible causes, or non-cardiac causes. 3. Severe left ventricular enlargement, defined as left ventricular anteroposterior diameter greater than 80 mm. 4. Left ventricular ejection fraction of 35% or less. 5. New York Heart Association functional class III or IV. 6. 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. 7. Significant congenital cardiac anatomical abnormalities that prevent the ablation catheter from accessing the target ablation area. 8. 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. 9. Intracardiac thrombus, myxoma, occlusion device, or other condition that may interfere with catheter insertion or manipulation. 10. Severe vascular access obstruction, such as an implanted inferior vena cava filter or mural thrombus. 11. Uncontrolled hypertension, defined as persistent systolic blood pressure of 180 mmHg or higher or persistent diastolic blood pressure of 110 mmHg or higher. 12. Severe restrictive or obstructive pulmonary disease or chronic respiratory disease that, in the investigator's judgment, makes the participant unsuitable for cardiac intervention. 13. Obvious bleeding tendency or hematologic disease. 14. Untreated or uncontrolled hyperthyroidism or hypothyroidism. 15. 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. 16. Unstable angina or acute myocardial infarction within 3 months before enrollment. 17. Percutaneous coronary intervention or coronary artery bypass grafting within 3 months before enrollment. 18. Stroke or transient ischemic attack within 3 months before enrollment. 19. Thromboembolic disease. 20. Clear contraindication to interventional procedures or ablation as determined by the investigator. 21. Pregnancy, lactation, or planned pregnancy during the study period. 22. Participation in another drug or medical device clinical trial within 3 months before enrollment. 23. Any condition that, in the investigator's judgment, makes the participant unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Procedural Success Rate | At the end of the ablation procedure, after a 30-minute post-ablation observation period | 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. |
| Treatment Success Rate at 6 Months After Ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Procedure Time | During the ablation procedure | The total duration of the ablation procedure, as recorded in the procedural record, will be reported in minutes. |
| Total Pulsed Field Ablation Delivery Time | During the ablation procedure | The cumulative duration of pulsed field energy delivery during the ablation procedure will be recorded and reported in seconds. |
| Number of Pulsed Field Ablation Applications | During the ablation procedure | The total number of pulsed field ablation applications delivered during the ablation procedure will be recorded for each participant. |
| Percentage of Participants With Death, Stroke, or Transient Ischemic Attack | From enrollment through 6 months after ablation | The percentage of participants who experience at least one of the following events will be reported: all-cause death, stroke, or transient ischemic attack. |
| Percentage of Participants With Procedure-Related Complications | From the ablation procedure through 6 months after ablation | 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. |
| Percentage of Participants With Pulsed Field Ablation-Related Complications | From the ablation procedure through 6 months after ablation | 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. |
| Change From Baseline in EQ-5D-5L Index Score | Baseline, 3 months, and 6 months after ablation | 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. |
| Change From Baseline in SF-36 Score | Baseline, 3 months, and 6 months after ablation | 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. |
Contacts
CONTACTHongtao Wang
Outcome results
None listed