Clinical trial NCT05618340: PFA for Paroxysmal Atrial Fibrillation
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: pulse field ablation
PFA
Paroxysmal Atrial Fibrillation
PAF
Lead sponsor: Shanghai Shangyang Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-16
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This trial is a prospective, multicenter, single-group target value method study
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Treatment Success at 3-Month Post-Procedure
timeFrame: Refers to the postoperative phase (blank) after 3 months postoperatively
measure: Rate of Treatment Success at 6-Month Post-Procedure
timeFrame: Refers to the postoperative phase (blank) after 6 months postoperatively
measure: Rate of Treatment Success at 12-Month Post-Procedure
timeFrame: Refers to the postoperative phase (blank) after 12 months postoperatively
Secondary outcomes:
measure: Immediate success rate: pulmonary vein isolation after ablation
timeFrame: 1 Day of surgery
measure: Evaluation of Pulse Ablation Catheter
timeFrame: 1 Day of surgery
measure: Evaluation of Pulse Ablation equipment
timeFrame: 1 Day of surgery
Other outcomes:
measure: The incidence of early onset (within 7 days of ablation) adverse events
timeFrame: Within 7 days after the surgery
measure: Incidence of adverse events and serious adverse events associated with the study device
timeFrame: Within 12 months after sign the informed consent form
Locations:
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenhe District, Shenyang, Liaoning Province
state: Liaoning
Study officials:
References: