Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation

N/ANot Yet RecruitingNCT07811934

Shanghai Shineyo Medical Co., Ltd.284 enrolled

Overview

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

Interventions

Investigational Cardiac Pulsed Field Ablation (PFA) SystemDEVICE

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.

Conventional Radiofrequency (RF) Catheter Ablation SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Medical conditions that may interfere with study participation, assessment or treatment, significantly increase study-related risk, or alter study outcomes, including but not limited to: moderate-to-severe COPD, moderate-to-severe pulmonary hypertension, or diseases causing severe dyspnea or resting hypoxemia; renal insufficiency (eGFR\<30 ml/min/1.73 m²) or history of hemodialysis or renal transplantation; active malignancy or treated malignancy within 24 months prior to enrollment (excluding basal cell or squamous cell skin carcinoma); active systemic infection * Myocardial infarction, unstable angina, heart failure hospitalization within 3 months prior to enrollment; any cardiac interventional or open-heart surgery within 1 month prior to enrollment (coronary angiography excluded) * Stroke (excluding silent stroke), transient ischemic attack or any thromboembolic event within 3 months prior to enrollment * Expected survival less than 1 year * Female subjects who are pregnant, lactating, or planning pregnancy during study period * Participation in another interventional device clinical trial within 1 month before enrollment, or within 5 half-lives of last study drug for drug clinical trials * Any other condition judged by investigator to make the subject unsuitable for this clinical trial

Outcomes

Primary Outcomes

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).

Time frame: 12 months post-index ablation

Secondary Outcomes

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

Time frame: 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

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

Atrial fibrillation burden assessed by 72-hour Holter monitoring

Time frame: 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

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

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

Time frame: 1-month and 3-month post-index ablation

Proportion of participants receiving electrical cardioversion, repeat ablation, emergency department visit or hospitalization due to documented recurrent atrial arrhythmia

Time frame: Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation

Proportion of participants with re-initiation of antiarrhythmic drugs

Time frame: 1-month, 3-month, 6-month, 12-month post-index ablation

Time from index ablation to first documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia

Time frame: Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits

Symptom-free survival of participants

Time frame: 1-month, 3-month, 6-month, 12-month post-index ablation

Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) total score from baseline

The change from baseline in the total score of the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire. Measurement tool: AFEQT questionnaire. Unit: score.

Time frame: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation

Performance evaluation of investigational device

Time frame: On the day of index ablation

Incidence of major adverse events

Time frame: Within 7 days post-index ablation and up to 12 months post-index ablation

Incidence of device- or procedure-related stroke or transient ischemic attack (TIA)

Number of subjects experiencing device- or procedure-related stroke or transient ischemic attack (TIA). Unit: percentage of subjects.

Time frame: Through study completion, average of 12-month follow-up

Incidence of device- related serious adverse events (SAE)

Number of device-related serious adverse events divided by the total number of serious adverse events that occurred during follow-up. Measurement tool: clinical adverse-event reporting. Unit: percentage of SAE events.

Time frame: Through study completion, average of 12-month follow-up

Laboratory values of myocardial injury biomarkers

Laboratory values of myocardial injury biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: laboratory value.

Time frame: Within 48-hours post-index ablation

Incidence of hemolysis-associated renal injury

Number of subjects with hemolysis-associated renal injury occurring within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: percentage of subjects.

Time frame: Within 48-hours post-index ablation

Incidence of other adverse events (AE)

Number of subjects experiencing other adverse events (AEs) throughout the study period. Unit: percentage of subjects.

Time frame: Through study completion, average of 12-month follow-up

Total index ablation procedure duration

Total time duration of the index ablation procedure. Unit: minutes.

Time frame: Periprocedural

Left-atrial device dwell time during index ablation

Total dwell time of investigational device within left atrium during index ablation. Unit: minutes.

Time frame: Periprocedural

Pulmonary vein isolation (PVI) procedural time

Time spent for pulmonary vein isolation (PVI) manipulation during index ablation. Unit: minutes.

Time frame: Intra-procedural

Total fluoroscopy time during index ablation

Total fluoroscopy exposure time during index ablation. Unit: minutes.

Time frame: Intra-procedural

Total contrast media volume administered

Total volume of contrast media used during index ablation. Unit: mL.

Time frame: Intra-procedural

Number of ablation energy deliveries

Total count of ablation energy deliveries applied during index ablation. Unit: number of subjects (count).

Time frame: Intra-procedural

Incidence of other serious adverse events (SAE) throughout the study period

Number of subjects with other serious adverse events occurring during the entire study period. Measurement tool: serious adverse-event reporting. Unit: percentage of subjects.

Time frame: Through study completion, average of 12-month follow-up

Laboratory values of inflammatory biomarkers

Laboratory values of inflammatory biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: laboratory value.

Time frame: Within 48-hours post-index ablation

Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility score from baseline

The change from baseline in the utility index score calculated from the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Measurement tool: EQ-5D-5L questionnaire. Unit: index score.

Time frame: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation

Proportion of procedure-related serious adverse events (SAEs) among all SAEs

Number of procedure-related serious adverse events divided by the total number of serious adverse events that occurred during follow-up. Measurement tool: clinical adverse-event reporting. Unit: percentage of SAE events.

Time frame: Through study completion, average of 12-month follow-up

Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts