Status:
RECRUITING
The Safety and Efficacy of Radiofrequency Ablation After Left Atrial Appendage Occlusion.
Lead Sponsor:
Affiliated Hospital of Nantong University
Conditions:
Cardiovascular Diseases
Arrhythmia
Eligibility:
All Genders
18-80 years
Brief Summary
Objective: To evaluate the safety and efficacy of transcatheter atrial fibrillation ablation 1 month after WATCHMAN FLX left atrial appendage closure in patients with nonvalvular atrial fibrillation.
Detailed Description
Atrial fibrillation (AF) is one of the most common persistent arrhythmias in the clinic, and its incidence increases significantly with age, posing a serious threat to public health worldwide. One of ...
Eligibility Criteria
Inclusion
- ≥18 years of age, diagnosed with nonvalvular atrial fibrillation;
- Meet the indications for receiving WATCHMAN FLX left atrial appendicular closure and transcatheter atrial fibrillation ablation;
- Preoperative imaging evaluation showed that the anatomical structure of the left atrial appendage was suitable for implantation with the WATCHMAN FLX device;
- The patient agrees to participate in the study and signs the informed consent.
Exclusion
- valvular heart disease or other structural heart disease that causes atrial fibrillation;
- left auricular thrombus or acute thrombotic event was found before surgery;
- Patients with severe bleeding tendency or recent major bleeding events (such as massive gastrointestinal bleeding, cerebral hemorrhage, etc.);
- Patients who are unable to complete postoperative follow-up (such as life expectancy of less than 1 year or poor compliance);
- Other serious diseases (such as liver and kidney failure, active infection, etc.) were found in preoperative examination;
- Pregnant or lactating women.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06984731
Start Date
April 21 2025
End Date
June 1 2028
Last Update
May 22 2025
Active Locations (1)
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1
Affiliated hospital of Nantong University
Nantong, Jiangsu, China, 226001