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

NCT06157437 | Recruiting

• 1 other identifier: fPFA001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Acute procedural success

  Acute procedural success is defined as the creation of bidirectional conduction block across the cavo-tricuspid isthmus immediately and 30 minutes after ablation.

  immediately after the procedure

Secondary Outcomes (4)

• Chronic success

  6 months after procedure

• Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time

  immediately after the procedure

• Incidence of device-related major adverse events (MAE) within 7 days after ablation

  within 7 days after ablation

• Incidence of device-related severe adverse events (SAE)

  3 months and 6 months after procedure

Study Arms (1)

Focal pulse ablation system

EXPERIMENTAL

Device: Focal Pulse field Ablation

Interventions

Focal Pulse field Ablation DEVICE

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

Focal pulse ablation system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Dinova EP Technology Co., Ltd: lead

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Haitao Yang

CONTACT

+8637158680341; dinova_ep@dnaeps.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)