Evaluating safety and effectiveness of radiofrequency ablation after left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and efficacy of transcatheter atrial fibrillation ablation performed one month after the WATCHMAN FLX left atrial appendage closure in patients diagnosed with nonvalvular atrial fibrillation. Atrial fibrillation is a common arrhythmia that significantly increases the risk of stroke, particularly from thrombi originating in the left atrial appendage. The study will involve patients who meet specific criteria for both the WATCHMAN device implantation and subsequent radiofrequency ablation, focusing on improving rhythm control and reducing stroke risk. The findings could provide valuable insights into the combined approach of these two interventions for better patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Affiliated hospital of Nantong University
  Nantong, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Qi Lu MD
• Email: luqint@sina.com
• Phone: +8613962989292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.