Premature Ventricular Contractions
Conditions
Keywords
intracardiac echocardiography, papillary muscle-originating premature ventricular contractions, premature ventricular contractions
Brief summary
This randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ICE)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing PVC recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (PVCs). Participants were randomly allocated to either the ICE-guided intervention group or the conventional ablation control group following definitive diagnosis.
Interventions
PROCEDUREintracardiac echocardiography (ICE)-guided catheter ablation
Intracardiac echocardiography (ICE)-guided catheter ablation.
PROCEDUREPressure-sensing catheter ablation alone
Pressure-sensing catheter ablation alone
Sponsors
The Second People's Hospital of Anhui Province
The First People's Hospital of Hefei
Qilu Hospital of Shandong University
Fujian Medical University Union Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Shanghai Chest Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 years. * Diagnosed with premature ventricular contractions (PVCs) originating from the papillary muscles. * Symptoms refractory to antiarrhythmic drug therapy. * Patients must be capable and willing to provide written informed consent for study participation.
Exclusion criteria
* History of cardiac surgery or any prior cardiac interventional procedures. * Ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. * Severe hepatic or renal dysfunction: AST/ALT \>3× upper limit of normal (ULN); Serum creatinine (SCr) \>3.5 mg/dl or creatinine clearance (Ccr) \<30 ml/min. * Prior ablation for papillary muscle PVCs. * Life expectancy \<1 year. * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from VC recurrence | Patients were followed up at 3 months postoperatively to assess recurrence. | Freedom from VC recurrence (defined as a ≥80% reduction in VC burden, calculated as \[number of VCs per 24 hours / total number of heartbeats per 24 hours\] × 100%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VC burden reduction | Patients were followed up at 3 months postoperatively to assess recurrence. | Preoperative VC burden \[%\] - postoperative VC burden \[%\]. |
| Total procedure time | From the start to the end of the procedure. | Total procedure time. |
| Total fluoroscopy time | From the start to the end of the procedure. | Total fluoroscopy time. |
| Major perioperative complications | 30 days postoperatively. | Including cardiac tamponade, atrioventricular block, stroke, or pulmonary embolism. |
Countries
China
Outcome results
None listed