A Dual Energy Catheter (PFA and RFA) and a PFA Catheter for the Treatment of PeAF

NCT06232798 | Completed

• 1 other identifier: 775046
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Persistent Atrial Fibrillation

Keywords

PFA; PeAF; PFA/RF

Outcome Measures

Primary Outcomes (1)

• Immediate success rate

  Refers to the proportion of the number of subjects electrically isolated in each AF patient after surgery to the total number of subjects enrolled.

  1 Day of catheter ablation

Secondary Outcomes (1)

• Ablation success at 3-month after the catheter ablation

  3 months

Study Arms (1)

A prospective, singlecenter, single-arm clinical study

EXPERIMENTAL

Other: a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter; Other: catheter ablation

Interventions

a dual energy catheter (RF and PFA) or PFA catheter only will be to treat PeAF,Cardiac Pulsed Electric Field Ablation Catheter OTHER

This study will be used two catheters, the contact force sensing catheter able to deliver both RF and PFA energy, this catheter provides both the radiofrequency (RF) energy and pulsed field ablation (PFA) energy to the catheter through the toggling of the two energy sources on the generator monitor. Another catheter is PFA catheter only.

A prospective, singlecenter, single-arm clinical study

catheter ablation OTHER

catheter ablation

Also known as: operation

A prospective, singlecenter, single-arm clinical study

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients who have undergone left atrial surgery
• Left atrial thrombosis
• Patients with combined atrial tachycardia and atypical atrial flutter
• Patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment
• Anterior and posterior left atrial diameter ≥ 55mm
• 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
• 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

Sponsors & Collaborators

• Shanghai MicroPort EP MedTech Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Desmoglein 1; Catheter Ablation; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens; Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 31, 2024
• Study Start: January 11, 2024
• Primary Completion: September 10, 2024
• Study Completion: April 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

CN (1)