Clinical trial NCT06232798: A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF
Official title: A Single-Center, Exploratory Clinical Study Combining Radiofrequency and Pulsed Field Ablation for Persistent Atrial Fibrillation Based on Columbus™ 3D EP Navigation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: PFA
PeAF
PFA/RF
Lead sponsor: Shanghai MicroPort EP MedTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 10
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: A prospective, singelcenter, single-arm clinical study to evaluate the safety and efficacy of PFA/RF catheter or PFA catheter for the treatment of persistent atrial fibrillation
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with PFA/RFA. 10 patients will be treated by PFA/RFA catheter or PFA catheter only.

Participants will followed 1、3 month after catheter ablation


Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 years old;
2. Documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year；
3. Ineffective or intolerable after treatment with at least one Class I or Class III antiarrhythmic drug;
4. 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:

1. Patients who have undergone left atrial surgery
2. Left atrial thrombosis
3. Patients with combined atrial tachycardia and atypical atrial flutter
4. Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
5. Anterior and posterior left atrial diameter ≥ 55mm
6. Left ventricular ejection fraction (LVEF) ≤ 40%
7. Previous atrial septal repair or atrial mucinous tumor
8. Active implants (e.g. pacemakers, ICDs, etc.) in the body
9. NYHA class III-IV cardiac function
10. Clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack)
11. 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)
12. Those with acute or severe systemic infections
13. 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
14. Patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders
15. Patients who have participated or are participating in other clinical trials within 3 months prior to enrollment
16. Patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Primary outcomes:
measure: Immediate success rate
timeFrame: 1 Day of catheter ablation
Secondary outcomes:
measure: Ablation success at 3-month after the catheter ablation
timeFrame: 3 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: