Evaluating safety and effectiveness of radiofrequency ablation after left atrial appendage closure
Clinical Trial Protocol for Safety and Efficacy of Transcatheter Ablation After Left Atrial Appendicular Occlusion With WATCHMAN FLX
This study is testing if a heart procedure called radiofrequency ablation is safe and effective for people with atrial fibrillation after they have had a device placed to close off a part of their heart to reduce stroke risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT06984731 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with nonvalvular atrial fibrillation who are suitable for both left atrial appendage closure and radiofrequency ablation.
Not a fit: Patients with valvular heart disease, severe bleeding tendencies, or those unable to comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance stroke prevention and improve heart rhythm control in patients with atrial fibrillation.
How similar studies have performed: While the combination of these interventions is promising, the specific approach of this study has not been extensively tested in prior research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nantong, Jiangsu
- Affiliated hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Qi Lu MD
- Email: luqint@sina.com
- Phone: +8613962989292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.