An Exploratory Study of Focal Pulse Ablation System in the Treatment of Atrial Arrhythmia

NCT ID: NCT06157437

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2025-06-30

Brief Summary

This is a prospective, single-group clinical study. The objective is to evaluate the safety and efficacy of focal pulse ablation system in the treatment of typical atrial flutter.

Conditions

Typical Atrial Flutter; Atrial Fibrillation (AF)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Focal pulse ablation system

Group Type: EXPERIMENTAL

Focal Pulse field Ablation

Intervention Type: DEVICE

Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.

Interventions

Focal Pulse field Ablation

Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects aged at least 18;
• Subjects with at least one typical atrial flutter attack recorded by ECG or holter in the 180 days prior to enrollment, and the ECG of other hospitals could be accepted;
• Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.

Exclusion Criteria

• Any prior cavo-tricuspid isthmus ablation;
• Unstable angina;
• Atrial flutter secondary to electrolyte disorder, thyroid disease or other reversible causes;
• Myocardial infarction or coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the prior three months;
• At baseline, New York College of Cardiology (NYHA) heart function grades III and IV;
• Implantable devices such as ICDs, CRTS and pacemakers in the body;
• Atrial or ventricular tumors, blood clots, thrombus, or known clotting disorders were recorded within the prior 90 days;
• Severe structural heart disease, including tricuspid stenosis, tricuspid malformation, or other congenital heart disease that prevents ablation surgery;
• Previously received tricuspid metal valve replacement;
• Thromboembolic events (including transient ischemic attacks) within the past 6 months;
• Mural thrombosis, tumor, or other abnormality that interferes with vascular puncture or catheter operation;
• Severe lung disease, pulmonary hypertension or any lung disease involving abnormal blood gas or severe breathing difficulties;
• Anticoagulation contraindications and a history of blood clotting or abnormal bleeding;
• Acute systemic infection;
• Serum creatinine greater than twice the upper limit of normal, or any history of renal dialysis;
• Women who are pregnant or breastfeeding or who cannot use contraception during the study period;
• Enrollment in another clinical trial evaluating other devices or drugs during the same period;
• Life expectancy less than 12 months (e.g. advanced malignancy);
• Abnormalities or diseases considered by the investigator to be excluded from inclusion in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Dinova EP Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haitao Yang

Role: CONTACT

dinova_ep@dnaeps.com

+8637158680341

Facility Contacts

Ming Tang

Role: primary

doctortangmin@sina.com

+8613810665178

Other Identifiers

fPFA001

Identifier Type: -

Identifier Source: org_study_id