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Clinical study on the efficacy and safety of disposable cardiac pressure pulsed electric field radiofrequency ablation catheter for the treatment of ventricular arrhythmias

Clinical study on the efficacy and safety of disposable cardiac pressure pulsed electric field radiofrequency ablation catheter for the treatment of ventricular arrhythmias

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078316
Enrollment
Unknown
Registered
2023-12-05
Start date
2023-12-05
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ventricular arrhythmias

Interventions

ventricular arrhythmias:using pulsed electric fields to ablate ventricular arrhythmias

Sponsors

The First Affiliated Hospital of USTC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old (inclusive) 2. Patients with clinical diagnosis of outflow tract related ventricular arrhythmias, indications for radiofrequency ablation, and planning to undergo pulsed electric field ablation surgery 3. Voluntarily participated in this experiment and signed an informed consent form 4. Willing to follow the relevant requirements of this experiment and cooperate in completing the corresponding follow-up

Exclusion criteria

Exclusion criteria: 1 Left ventricular ejection fraction (LVEF) = 40% 2 Cardiac function NYHA level III-IV 3 Previous unsuccessful or recurrent cases of radiofrequency ablation 4 pregnant women 5 Having a clear tendency to bleed or suffering from hematological diseases 6 Patients with acute or severe systemic infections, significant abnormalities in liver and kidney function (laboratory test values higher than twice the normal range), or malignant tumors and end-stage diseases 7 Preoperative determination of the presence of two or more types of tachyarrhythmias 8 Concomitant with severe organic cardiovascular disease 9 Stroke and other cerebrovascular diseases within the past 3 months 10 thromboembolic disease 11 Researchers determine patients who are not suitable for participation

Design outcomes

Primary

MeasureTime frame
Immediate success rate of surgery;Treatment success rate at 6 months after surgery;

Secondary

MeasureTime frame
Surgical time;discharge time;X-ray exposure time;

Countries

China

Contacts

Public ContactJian Xu

The First Affiliated Hospital of USTC

958532006@qq.com+86 551 6228 4132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026