Ventricular arrhythmia
Conditions
Interventions
Pulse ablation group:Use of a disposable magnetic field-guided pressure-monitoring Pulsed Field Ablation catheter (Huikang) in combination with the HT-9000 PRO 3D mapping system
Radiofrequency ablation group:Use of ThermoCool SmartTouch ST or SF catheter for standard radiofrequency ablation with usual power settings
Sponsors
Weifang People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >=18 years. (2) Drug-refractory idiopathic PVCs with a 24-h Holter burden = 10 % or sustained monomorphic VT (>= 3 beats) documented on ECG or EP study. (3)Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: (1)Hemodynamically unstable heart failure (e.g., NYHAClass III-IV or acute decompensation) or severe valvular heart disease requiring surgical intervention. (2)Prior history of aborted sudden cardiac death (SCD) or survivors of cardiac arrest. (3)Pregnancy or lactation. (4)Implanted cardioverter-defibrillator (ICD) with a history of frequent appropriate or inappropriate shocks within the recent [3/6] months. (5)Severe hepatic or renal impairment, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN); serum creatinine (SCr) >3.5 mg/dL; or calculated creatinine clearance (CrCl) <30 mL/min. (6)Known contraindications to radiofrequency ablation, electrophysiology (EP) study, or anticoagulation therapy contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is sustained arrhythmia-free survival at 6 months;The primary safety endpoint is the incidence of Major Adverse Cardiac Events (MACE) within 30 days post-procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical efficiency: total procedure time, fluoroscopy time and radiation dose (mGy value);Pain assessment (VAS);Quality of life (SF-36); | — |
Countries
China
Contacts
Public ContactChen Yanbo
Weifang People's Hospital
Outcome results
None listed