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Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation

NCT06039722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-06-19

No results posted yet for this study

Summary

This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%.

Principle evaluation indexes：

1. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
2. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
3. Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.

Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%

Secondary evaluation indexes：

1. The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
2. Device performance evaluation;

Safety evaluation indexes：

1. The occurrence of death, stroke, or transient ischemic attack;
2. The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc;
3. Clinically significant vital signs and related examinations;
4. The occurrence of other adverse events and serious adverse events during the trial period.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Pulse ablation catheter

Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential

Sponsors & Collaborators

  • Shenzhen Pulsecare Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2024-08-29
Completion
2024-08-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039722 on ClinicalTrials.gov