Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)

NCT05114954 | Completed DMC

• 1 other identifier: PFA001
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the treatment of patients with paroxysmal atrial fibrillation

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The effectiveness of the pulsed field ablation system in the treatment of paroxysmal atrial fibrillation is evaluated by the 12-month ablation success rate of atrial fibrillation.

  12-month ablation success rate of atrial fibrillation is defined by ECG data (including ECG and 24-hour dynamic electrocardiogram (Holter)) during the effective evaluation period (blanking period to the end of 12-month follow-up), without recording AF, AFL or AT (Arrhythmia monitoring device ≥ 30 seconds).

  12 months after the ablation

Secondary Outcomes (5)

• Acute isolation success rate

  20 minutes after the ablation

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

  immediately after the ablation

• Incidence of device-related or operating-related major adverse events (MAE) 3 months after surgery

  3 months after the ablation

• Incidence of severe adverse events

  12 months after the ablation

• Incidence of device-related adverse events

  12 months after the ablation

Study Arms (1)

Experiment group

EXPERIMENTAL

Patients treated with PFA catheter.

Device: CardioPulsesTM pulsed field ablation system

Interventions

CardioPulsesTM pulsed field ablation system DEVICE

Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.

Experiment group

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 to 75 years old;
• Patients diagnosed with symptomatic paroxysmal atrial fibrillation:
• At least 1 ECG or rhythm monitoring documented AF episode within 12 months prior to enrollment.
• Ineffective or intolerant of at least one antiarrhythmic drug;
• Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.

You may not qualify if:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible cause;
• Persistent or long-standing persistent AF;
• Previous surgery or catheter ablation for AF;
• Participant known to require ablation outside the pulmonary vein or in cavotricuspid isthmus region (such as atrioventricular reentrant tachycardia, atrioventricular nodalreentry tachycardia, atrial tachycardia, atrial flutter, ventricular tachycardia and Wolff-Parkinson-White syndrome);
• Previous valve repair, replacement or artificial valve implantation; previous atrial septal defect closure, patent foramen ovale closure cardiac intervention or surgery;
• Previous left atrial appendage closure;
• Any myocardial infarction (MI), coronary artery bypass grafting (CABG) procedure or percutaneous coronary intervention (PCI) during the 6-month interval preceding the consent date;
• Any carotid artery stent implantation or endarterectomy within the previous 6 months;
• Left atrial diameter≥50 mm (anteroposterior);
• LVEF \<40% on admission, or NYHA class III and IV;
• Presence of implanted ICD, CRT, permanent pacemaker, or any type of implantable device
• Documented active thrombus in the left atrium or atrial appendage on imaging;
• Rheumatic heart disease;
• Uncontrollable high blood pressure;
• Hypertrophic cardiomyopathy, myocardial thickening was significantly greater than or equal to 15mm;

Sponsors & Collaborators

• Hangzhou Dinova EP Technology Co., Ltd: lead

Study Sites (1)

General Hospital of the Northern Theater of the Chinese People's Liberation Army

Shenyang, China

Location

Related Publications (1)

• Wang Z, Tang M, Reddy VY, Chu H, Liu X, Xue Y, Wang J, Xu J, Liu S, Xu W, Zhang Z, Han B, Hong L, Yang B, Ding M, Liang M. Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF study. Europace. 2024 Jul 2;26(7):euae174. doi: 10.1093/europace/euae174.

  PMID: 38912887 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

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: October 21, 2021
• First Posted: November 10, 2021
• Study Start: October 27, 2021
• Primary Completion: June 30, 2022
• Study Completion: March 30, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

CN (1)