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Single-Use Spherical Pulsed Ablation Catheter for Paroxysmal Atrial Fibrillation

3 september 2026 bijgewerkt door: Shanghai Shineyo Medical Co., Ltd.

A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Trial Evaluating the Safety and Efficacy of Cardiac Pulsed Field Ablation Devices Combined With Single-use Spherical Pulsed Ablation Catheters in Treating Paroxysmal Atrial Fibrillation

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

284

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Investigational Cardiac Pulsed Field Ablation (PFA) Arm
Intervention group receiving cardiac pulsed field ablation for paroxysmal atrial fibrillation
Apparaat: Investigational Cardiac Pulsed Field Ablation (PFA) System
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.
Actieve vergelijker: Control Radiofrequency (RF) Catheter Ablation Arm
Control group receiving conventional radiofrequency catheter ablation for paroxysmal atrial fibrillation
Apparaat: Conventional Radiofrequency (RF) Catheter Ablation System
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with freedom from atrial fibrillation at 12 months post-index ablation (90-day post-procedure blanking period)
Tijdsspanne: 12 months post-index ablation
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with treatment success at 12 months post-index ablation
Tijdsspanne: From the end of 30-day post-procedure blanking period to 12 months after the 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
Tijdsspanne: On the day of index ablation (intra-procedure completion)
On the day of index ablation (intra-procedure completion)
Atrial fibrillation burden assessed by 72-hour Holter monitoring
Tijdsspanne: 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
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
Tijdsspanne: 2 hours after recovery from anesthesia; 24 hours post-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)
Tijdsspanne: 1-month and 3-month post-index ablation
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
Tijdsspanne: Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation
Prior to hospital discharge, 1-month, 3-month, 6-month, 12-month post-index ablation
Proportion of participants with re-initiation of antiarrhythmic drugs
Tijdsspanne: 1-month, 3-month, 6-month, 12-month post-index ablation
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
Tijdsspanne: Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits
Up to 12-month post-index ablation, assessed at 1-,3-,6-,12-month visits
Symptom-free survival of participants
Tijdsspanne: 1-month, 3-month, 6-month, 12-month post-index ablation
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
Tijdsspanne: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
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.
Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
Performance evaluation of investigational device
Tijdsspanne: On the day of index ablation
On the day of index ablation
Incidence of major adverse events
Tijdsspanne: Within 7 days post-index ablation and up to 12 months post-index ablation
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)
Tijdsspanne: Through study completion, average of 12-month follow-up
Number of subjects experiencing device- or procedure-related stroke or transient ischemic attack (TIA). Unit: percentage of subjects.
Through study completion, average of 12-month follow-up
Incidence of device- related serious adverse events (SAE)
Tijdsspanne: Through study completion, average of 12-month follow-up
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.
Through study completion, average of 12-month follow-up
Laboratory values of myocardial injury biomarkers
Tijdsspanne: Within 48-hours post-index ablation
Laboratory values of myocardial injury biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: laboratory value.
Within 48-hours post-index ablation
Incidence of hemolysis-associated renal injury
Tijdsspanne: Within 48-hours post-index ablation
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.
Within 48-hours post-index ablation
Incidence of other adverse events (AE)
Tijdsspanne: Through study completion, average of 12-month follow-up
Number of subjects experiencing other adverse events (AEs) throughout the study period. Unit: percentage of subjects.
Through study completion, average of 12-month follow-up
Total index ablation procedure duration
Tijdsspanne: Periprocedural
Total time duration of the index ablation procedure. Unit: minutes.
Periprocedural
Left-atrial device dwell time during index ablation
Tijdsspanne: Periprocedural
Total dwell time of investigational device within left atrium during index ablation. Unit: minutes.
Periprocedural
Pulmonary vein isolation (PVI) procedural time
Tijdsspanne: Intra-procedural
Time spent for pulmonary vein isolation (PVI) manipulation during index ablation. Unit: minutes.
Intra-procedural
Total fluoroscopy time during index ablation
Tijdsspanne: Intra-procedural
Total fluoroscopy exposure time during index ablation. Unit: minutes.
Intra-procedural
Total contrast media volume administered
Tijdsspanne: Intra-procedural
Total volume of contrast media used during index ablation. Unit: mL.
Intra-procedural
Number of ablation energy deliveries
Tijdsspanne: Intra-procedural
Total count of ablation energy deliveries applied during index ablation. Unit: number of subjects (count).
Intra-procedural
Incidence of other serious adverse events (SAE) throughout the study period
Tijdsspanne: Through study completion, average of 12-month follow-up
Number of subjects with other serious adverse events occurring during the entire study period. Measurement tool: serious adverse-event reporting. Unit: percentage of subjects.
Through study completion, average of 12-month follow-up
Laboratory values of inflammatory biomarkers
Tijdsspanne: Within 48-hours post-index ablation
Laboratory values of inflammatory biomarkers collected within 48-hours post-index ablation or prior to hospital discharge, whichever comes first. Unit: laboratory value.
Within 48-hours post-index ablation
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility score from baseline
Tijdsspanne: Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
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.
Baseline, 1-month, 3-month, 6-month, 12-month post-index ablation
Proportion of procedure-related serious adverse events (SAEs) among all SAEs
Tijdsspanne: Through study completion, average of 12-month follow-up
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.
Through study completion, average of 12-month follow-up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Shineyo Medical Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 maart 2028

Studie voltooiing (Geschat)

1 juni 2028

Studieregistratiedata

Eerst ingediend

20 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 september 2026

Eerst geplaatst (Werkelijk)

10 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

3 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • (2026)-(289)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual-participant-level data will not be shared with other researchers.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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