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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation (AF); Typical Atrial Flutter
• Intervention / Treatment: Device: Focal Pulse field Ablation

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haitao Yang; Phone Number: +8637158680341; Email: dinova_ep@dnaeps.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Contact: Ming Tang; Phone Number: +8613810665178; Email: doctortangmin@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focal pulse ablation system	Device: Focal Pulse field Ablation; Bidirectional block of the cavo-tricuspid isthmus (CTI) was performed with the novel focal pulse field ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic success	Chronic success is defined as the absence of recurrent atrial flutter at 6 months post-ablation according to electrocardiogram data, including electrocardiogram, 24-hour Holter.	6 months after procedure
Ablation efficiency including total procedure time, catheter dwell time, pulse discharge time and total X-ray exposure time	Total procedure time (defined as the total time from initial femoral venipuncture to final catheter removal), catheter dwell time (time between the pulsed field ablation catheter entering the left atrium and its withdrawal from the left atrium), pulse discharge time (The total time of delivering pulse energy through the pulsed field ablation catheter, single ablation time ablation times), total X-ray exposure time (the total time of X-ray imaging of the catheter)	immediately after the procedure
Incidence of device-related major adverse events (MAE) within 7 days after ablation	Device-related MAE includes death, myocardial infarction, pulmonary embolism, stroke /TIA, severe pericardial effusion, and complete atrioventricular block.	within 7 days after ablation
Incidence of device-related severe adverse events (SAE)	Device-related SAE refers to a device-related event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.	3 months and 6 months after procedure

Collaborators and Investigators

• Sponsor: Hangzhou Dinova EP Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: fPFA001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No