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

ConditionsCardiovascular DiseasesArrhythmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAffiliated Hospital of Nantong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

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);

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • left atrial appendage closure

    Procedure/Surgery

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

  • radiofrequency ablation

    Procedure/Surgery

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

Treatment groups

210 Participants
are divided into 1 treatment group
Group A: Experimental group2 interventions

Trial outcomes

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.

Time frame
one year

Secondary outcomes

1

Rate of adverse events

The incidence of surgery-related complications and adverse events occurring within 30 days post-procedure following left atrial appendage occlusion and radiofrequency ablation was evaluated. This included the incidence of pericardial effusion, procedural access site complications, vascular complications, and infections. The incidence of surgery-related complications and adverse events within 12 months post-procedure was assessed. This encompassed severe bleeding (defined as bleeding requiring blood transfusion or surgical intervention), pericardial tamponade, systemic embolism (including ischemic stroke and other embolic events), occluder-associated thrombosis (DRT), new or enlarged residual shunt (PDL, defined as \>5mm), postoperative acute left heart failure, and rehospitalization.

Time frame
one year
2

Arrhythmia recurrence during blanking period

The success rate of treatment within 3 months after radiofrequency ablation (early recurrence) : No recurrence of atrial arrhythmia ≥30 seconds;

Time frame
one year
3

Arrhythmia recurrence after blanking period

The success rate of treatment within 12 months after radiofrequency ablation (late recurrence) : There is no recurrence of atrial arrhythmia ≥30 seconds or more during the 4-12 months after the operation.

Time frame
one year
4

Incidence of stroke

Incidence of stroke within 12 months after left atrial appendage occlusion: No stroke occurred.

Time frame
one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital of Nantong University

Lead sponsor

Source ClinicalTrials.gov
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