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

NCT06984731 | Recruiting

• 1 other identifier: 2025-K080-01
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Arrhythmia

Keywords

Atrial Fibrillation (AF); Left Atrial Appendage closure with WATCHMAN device; Radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Treatment success at one year

  The success rate of complete left atrial appendage closure within 12 months post-WATCHMAN FLX left atrial appendage occlusion surgery, as evaluated by contrast-enhanced computed tomography angiography (CTA) of the left atrial appendage.

  one year

Secondary Outcomes (5)

• Rate of adverse events

  one year

• Arrhythmia recurrence during blanking period

  one year

• Arrhythmia recurrence after blanking period

  one year

• Incidence of stroke

  one year

• Quality of life changes at 12 months measured by AF Quality of Life Survey (AFEQT)

  one year

Study Arms (1)

Experimental group

Patients who meet the diagnosis of non-valvular atrial fibrillation and plan to receive sequential treatment of WATCHMAN FLX left atrial appendage occlusion and transcatheter atrial fibrillation ablation.

Procedure: left atrial appendage closure; Procedure: radiofrequency ablation

Interventions

left atrial appendage closure PROCEDURE

Patients with atrial fibrillation underwent transcatheter radiofrequency cardiac ablation 1 month after left atrial appendage closure with WATCHMAN FLX

Also known as: left atrial appendage closure with WATCHMAN FLX

Experimental group

radiofrequency ablation PROCEDURE

Patients with atrial fibrillation underwent transcatheter radiofrequency cardiac ablation 1 month after left atrial appendage closure with WATCHMAN FLX

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosed with symptomatic persistent atrial fibrillation, defined as: inability to spontaneously transition to sinus rhythm, lasting for more than 7 days, resistance or intolerance to at least Class I, II, or III antiarrhythmic drugs.

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Left Atrial Appendage Closure; Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques; Radiofrequency Therapy; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Qi Lu MD

CONTACT

+8613962989292; luqint@sina.com

Jian Zhang MD

CONTACT

13776926152

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 22, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)