Study on the Ablation of Persistent Atrial Fibrillation Using Pulsed Electric Fields Under Different Surgical Procedures

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for persistent atrial fibrillation (AF), a heart condition that causes an irregular heartbeat. The study aims to compare two different methods of heart ablation, a procedure that can help restore a normal heart rhythm. One group will receive a standard treatment called PVI (pulmonary vein isolation), while the other group will receive a more comprehensive approach that includes additional techniques. Researchers hope to learn more about how different parts of the heart contribute to AF and test the safety and effectiveness of a new technology called pulsed electric fields, which may offer a safer way to perform the ablation.

To participate in this trial, you need to be at least 18 years old and have persistent AF that hasn’t responded to medication. Unfortunately, some patients are not eligible, including those with severe heart conditions or other serious health issues. If you qualify and choose to take part, you'll be monitored for a year to see how well the treatment works and to ensure your safety. This study is an important step toward improving AF treatment and could lead to better outcomes for many patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years old and above, regardless of gender;
• • Patients with symptomatic drug-refractory persistent atrial fibrillation (diagnosis time exceeding ≤ 3 years);
• • Agree to participate in the study and be able and willing to comply with all follow-up requirements;-
• Exclusion Criteria:
• • Left ventricular ejection fraction (LVEF) ≤ 35%
• • Left atrial diameter (echocardiography) ≥ 55mm
• • Patients with a definite thrombus in the left atrium or a definite thrombus in the heart before surgery
• • Patients with cardiac function classification (NYHA) III-IV
• • Patients with second-degree (type II) or third-degree atrioventricular block
• • Persons with obvious congenital heart defects (such as atrial septal defect or severe pulmonary vein stenosis, but excluding patent foramen ovale)
• • Patients with prosthetic valve implantation
• • Patients with implanted cardiac pacemaker or cardiac defibrillator (ICD)
• • Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, myxoma
• • Patients with preoperatively known symptomatic carotid stenosis
• • Patients with untreated or controlled hyperthyroidism or hypothyroidism
• • Patients with systemically active infections
• • Patients with renal failure who have significant bleeding tendency or are undergoing hemodialysis
• • Patients with myocardial infarction or any cardiac intervention/open surgery within 3 months
• • Patients who have had a stroke or transient ischemic attack within 6 months
• • Patients with obvious contraindications to interventional surgery and who are judged by the investigator to be unable to undergo ablation surgery
• • Women who are pregnant or breastfeeding or who have a family planning during the study period
• • Patients who have participated in clinical trials of other drugs or medical devices within 3 months
• • Patients considered inappropriate by the investigator to participate in this clinical trial -