PFA for Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

A Study for the Effect and Safety of Cardiac Pulse Field Ablation System for Paroxysmal Atrial Fibrillation Guided by Columbus 3D EP Navigation System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05618340
• Other study ID #: DHF-SYPL-003(A)
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2023
• Source: Shanghai Shangyang Medical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application.

The trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. The effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 149
• Est. completion date: September 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• =18 and =75 years of age.

• Paroxysmal atrial fibrillation diagnosed by electrocardiogram or Holter ECG (including single-lead ECG recorder, lasting=30s) within 1 year prior to enrollment.

• Clinical diagnosis of paroxysmal atrial fibrillation.

• Symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication.

• Fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol.

Exclusion Criteria:

• Patients who have undergone left atrial surgery

• Left atrial thrombosis

• Patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment

• Anterior and posterior left atrial diameter = 50 mm

• Left ventricular ejection fraction (LVEF) = 40%

• Previous atrial septal repair or atrial mucinous tumor

• Active implants (e.g. pacemakers, ICDs, etc.) in the body

• NYHA class III-IV cardiac function [Appendix 1]

• Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)

• Cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy)

• Those with acute or severe systemic infections

• Patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial

• Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders

• Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment

• Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Pulsed electric field ablation device;Cardiac Pulsed Electric Field Ablation Catheter
Routinely placing a coronary sinus electrode catheter, puncturing the interatrial septum, placing one sheath into the left atrium, confirming that the catheter is well in place, and setting the treatment time of the pulse ablation system in advance. Pulmonary vein-by-pulmonary vein ablation using a circular pulse catheter, waiting for the end of the pulse ablation phase and immediate effect confirmation.

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Shangyang Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of early onset (within 7 days of ablation) adverse events	The primary safety endpoint	Within 7 days after the surgery
Other	Incidence of adverse events and serious adverse events associated with the study device	Secondary Security Endpoints	Within 12 months after sign the informed consent form
Primary	Rate of Treatment Success at 3-Month Post-Procedure	Refers to the postoperative phase (blank) after 3 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.	Refers to the postoperative phase (blank) after 3 months postoperatively
Primary	Rate of Treatment Success at 6-Month Post-Procedure	Refers to the postoperative phase (blank) after 6 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.	Refers to the postoperative phase (blank) after 6 months postoperatively
Primary	Rate of Treatment Success at 12-Month Post-Procedure	Refers to the postoperative phase (blank) after 12 months follow-up after process, without the use of class I and class III anti-arrhythmic drugs, by ECG, Holter, or Heart rate monitoring method based on equivalent (including a single lead electrocardiogram) confirmed that there are no last 30 s or af/the room/speed events account for the number of participants into the group of the proportion of the total number.	Refers to the postoperative phase (blank) after 12 months postoperatively
Secondary	Immediate success rate: pulmonary vein isolation after ablation	Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled. Validation was a 20-minute wait after successful electrical isolation of the pulmonary vein, followed by reconfirmation of pulmonary vein block	1 Day of surgery
Secondary	Evaluation of Pulse Ablation Catheter	Evaluation of catheter operation performance;Catheter ablation parameters	1 Day of surgery
Secondary	Evaluation of Pulse Ablation equipment	System software operability;System operation stability;Hardware connection validity	1 Day of surgery