The Safety and Efficacy of Radiofrequency Ablation After Left Atrial Appendage Occlusion.

Launched by AFFILIATED HOSPITAL OF NANTONG UNIVERSITY · May 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called radiofrequency ablation when done one month after a procedure known as left atrial appendage closure using the WATCHMAN FLX device. This study is aimed at adults aged 18 and older who have a heart condition called nonvalvular atrial fibrillation, which can cause irregular heartbeats. Participants will be carefully selected based on their health conditions, and they must meet specific criteria, such as having a suitable heart structure for the WATCHMAN FLX device and being able to commit to follow-up visits after the procedure.

If you or a loved one is considering participating in this trial, you can expect to undergo a thorough evaluation to determine if you qualify. The trial is currently recruiting participants, and everyone involved will need to provide consent to take part. It’s important to note that certain health issues, like severe bleeding disorders or other serious diseases, may prevent someone from joining the study. This trial aims to find out if the combination of these two treatments can help manage atrial fibrillation and improve heart health safely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥18 years of age, diagnosed with nonvalvular atrial fibrillation;
• • 2. Meet the indications for receiving WATCHMAN FLX left atrial appendicular closure and transcatheter atrial fibrillation ablation;
• • 3. Preoperative imaging evaluation showed that the anatomical structure of the left atrial appendage was suitable for implantation with the WATCHMAN FLX device;
• • 4. The patient agrees to participate in the study and signs the informed consent.
• Exclusion Criteria:
• • 1. valvular heart disease or other structural heart disease that causes atrial fibrillation;
• • 2. left auricular thrombus or acute thrombotic event was found before surgery;
• • 3. Patients with severe bleeding tendency or recent major bleeding events (such as massive gastrointestinal bleeding, cerebral hemorrhage, etc.);
• • 4. Patients who are unable to complete postoperative follow-up (such as life expectancy of less than 1 year or poor compliance);
• • 5. Other serious diseases (such as liver and kidney failure, active infection, etc.) were found in preoperative examination;
• • 6. Pregnant or lactating women.