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NCT06984731Recruiting

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

Clinical Trial Protocol for Safety and Efficacy of Transcatheter Ablation After Left Atrial Appendicular Occlusion With WATCHMAN FLX

Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
210 (estimated)
First submitted
22 Apr 2025
Start date
21 Apr 2025
Primary completion date
1 Jun 2027
Lead sponsor
Affiliated Hospital of Nantong University
NCT number
NCT06984731

What you commit to

  • Study type: Observational
  • Planned participants: 210
  • From 21 Apr 2025 to the primary completion date, 1 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • left auricular thrombus or acute thrombotic event was found before surgery;

Other illness

  • valvular heart disease or other structural heart disease that causes atrial fibrillation;
  • Patients with severe bleeding tendency or recent major bleeding events (such as massive gastrointestinal bleeding, cerebral hemorrhage, etc.);
  • Other serious diseases (such as liver and kidney failure, active infection, etc.) were found in preoperative examination;

Other

  • Patients who are unable to complete postoperative follow-up (such as life expectancy of less than 1 year or poor compliance);
  • Pregnant or lactating women.

Who the study is looking for

  • ≥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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Hospital of Nantong University
Coordinator of this site? Confirm its status
NantongChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.