Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation

NCT07811934 | Not Yet Recruiting

• 1 other identifier: (2026)-(289)
• Study Type: interventional
• Target: 284
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if the cardiac pulsed field ablation system, composed of the cardiac pulsed field ablation device, the single-use spherical pulsed ablation catheter, and the optional cardiac three-dimensional mapping system, works to treat symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation. It will also learn about the safety of this set of investigational medical devices. The main questions it aims to answer are: Does the combination of the cardiac pulsed field ablation device and the single-use spherical pulsed ablation catheter improve the 12-month post-procedure treatment success rate for participants with paroxysmal atrial fibrillation? What adverse events and medical problems do participants experience after receiving the investigational pulsed field ablation treatment? Researchers will compare the investigational pulsed field ablation therapy to the clinically recognized radiofrequency ablation therapy using the marketed Diagnostic/Ablation Deflectable Tip Catheter to verify the non-inferior effectiveness and safety of the test devices for treating paroxysmal atrial fibrillation. Participants will: Undergo screening assessments within 14 days before the procedure, including signing informed consent, completing medical history collection, physical vital sign checks, laboratory tests, 12-lead ECG, echocardiogram, baseline quality of life score evaluation, and confirmation of meeting all inclusion criteria without any exclusion criteria Be randomly assigned to either the investigational pulsed field ablation group or the control radiofrequency ablation group on the day of surgery Receive the assigned ablation procedure, with intra-operative recordings of core surgical parameters, pain score assessment, and investigational device performance evaluation Complete post-procedure assessments before discharge (within 7 days after surgery), including post-operative laboratory tests, pain follow-up, and recording of re-ablation, electrical cardioversion, readmission events, adverse events and concomitant medications Return for follow-up visits or complete telephone follow-ups at 1 month (±7 days), 3 months (±15 days), 6 months (±30 days) and 12 months (±30 days) after the procedure, which include physical vital sign checks, remote ECG monitoring (daily for the first 3 months after surgery, weekly from month 4 to month 12, and as needed when symptoms occur), 72-hour Holter and 12-lead ECG tests at the 6-month and 12-month visits, echocardiogram reexamination, repeated quality of life scoring, and continuous recording of arrhythmia recurrence, subsequent treatment events, adverse events and medication status Keep a symptom and ECG monitoring diary for the entire 12-month follow-up period after the procedure, as required by the trial protocol

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with freedom from atrial fibrillation at 12 months post-index ablation (90-day post-procedure blanking period)

  Treatment success at 12 months post-index ablation is defined as no amiodarone use and no repeat ablation during the 3-month post-procedure blanking period, except repeat ablation for CTI-dependent atrial flutter. Following the end of the blanking period (i.e., 3 months to 12 months after the procedure), subjects shall have no use of Class I/III antiarrhythmic drugs, no repeat ablation, no electrical cardioversion (interventions for CTI-dependent atrial flutter excluded), and no episodes of atrial fibrillation, atrial flutter, or atrial tachycardia lasting ≥30 seconds confirmed by electrocardiogram or Holter monitoring (CTI-dependent atrial flutter excluded).

  12 months post-index ablation

Secondary Outcomes (27)

• Proportion of participants with treatment success at 12 months post-index ablation

  From the end of 30-day post-procedure blanking period to 12 months after the index ablation

• Acute procedural success rate on the day of index ablation

  On the day of index ablation (intra-procedure completion)

• Atrial fibrillation burden assessed by 72-hour Holter monitoring

  6-month and 12-month follow-up; daily monitoring 1-3 months post-procedure, weekly monitoring 4-12 months post-procedure, additionally upon symptom occurrence

• Pain score at 2-hours and 24-hours after index ablation

  2 hours after recovery from anesthesia; 24 hours post-index ablation

• Recurrence rate of early atrial tachyarrhythmias (atrial fibrillation / atrial flutter / atrial tachycardia)

  1-month and 3-month post-index ablation

Study Arms (2)

Investigational Cardiac Pulsed Field Ablation (PFA) Arm

EXPERIMENTAL

Intervention group receiving cardiac pulsed field ablation for paroxysmal atrial fibrillation

Device: Investigational Cardiac Pulsed Field Ablation (PFA) System

Control Radiofrequency (RF) Catheter Ablation Arm

ACTIVE COMPARATOR

Control group receiving conventional radiofrequency catheter ablation for paroxysmal atrial fibrillation

Device: Conventional Radiofrequency (RF) Catheter Ablation System

Interventions

Conventional Radiofrequency (RF) Catheter Ablation System DEVICE

Using the commercially available diagnostic/ablation steerable-tip catheter in combination with a conventional clinical radiofrequency ablation device, point-by-point radiofrequency ablation is performed on the pulmonary vein antrum to achieve pulmonary vein electrical isolation. This is the current standard clinical treatment for paroxysmal atrial fibrillation.

Control Radiofrequency (RF) Catheter Ablation Arm

Investigational Cardiac Pulsed Field Ablation (PFA) System DEVICE

It consists of a cardiac pulsed electric field ablation apparatus and a single-use spherical pulsed ablation catheter, which can be paired with an optional cardiac three-dimensional mapping system to complete pulsed electric field ablation in the pulmonary vein antrum region, achieve pulmonary vein electrical isolation, and is indicated for the treatment of symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation.

Investigational Cardiac Pulsed Field Ablation (PFA) Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years, without gender restriction
• Patients with symptomatic, recurrent, drug-refractory paroxysmal atrial fibrillation
• Subjects scheduled for atrial fibrillation catheter ablation
• Subjects who agree to participate in this study and voluntarily sign the informed consent form

You may not qualify if:

• Persistent atrial fibrillation, or atrial fibrillation secondary to electrolyte disturbance, thyroid disease, alcohol or other reversible/non-cardiac causes
• Anterior-posterior left atrial diameter (measured by MRI, CT or TTE) ≥55 mm
• Prior history of any atrial surgery or atrial endocardial/epicardial ablation, except cavotricuspid isthmus ablation or right-sided supraventricular tachycardia ablation
• Existing left atrial thrombus, atrial myxoma, atrial septal patch or shunt device
• Prior or planned concomitant left atrial appendage closure procedure at index procedure
• Diagnosis of hypertrophic cardiomyopathy
• History of congenital heart disease with residual anatomical or conduction abnormalities
• Hemodynamically significant valvular heart disease judged by investigator to be ineligible for enrollment
• Prior valve repair or valve replacement surgery
• Implanted pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy device
• NYHA functional class Ⅲ-Ⅳ
• Left ventricular ejection fraction (LVEF) ≤40%
• Symptomatic hypotension or uncontrolled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>95 mmHg in two baseline measurements)
• Symptomatic resting bradycardia or type-second-degree or third-degree atrioventricular block
• Contraindication to systemic anticoagulation, or unwillingness to receive systemic anticoagulation

Sponsors & Collaborators

• Shanghai Shineyo Medical Co., Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Shuang Pan

CONTACT

86-18621903981; panshuang@shineyomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share