Left Atrial Appendage Closure in Combination With Catheter Ablation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

NCT04897204

Atrial Fibrillation Left Atrial Appendage Left Atrial Appendage Occlusion +1 more

UNKNOWN NA

Study of Safety and Efficacy of a Left Atrial Appendage Occulder

NCT02937025

Non-valvular Atrial Fibrillation Stroke

UNKNOWN PHASE1/PHASE2

Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke

NCT04479722

Atrial Fibrillation Stroke

ACTIVE_NOT_RECRUITING NA

Impact of Left Atrial Appendage Closure on Physical Capacity.

NCT03085693

Atrial Fibrillation

UNKNOWN

Catheter Ablation of Longstanding Persistent Atrial Fibrillation

NCT02929836

Atrial Fibrillation

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.

This study will be conducted in accordance with the following procedures:

1. Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
2. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.
3. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LAAC plus Catheter ablation

Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment.

left atrial appendage closure and catheter ablation

Intervention Type PROCEDURE

Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).

Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

left atrial appendage closure and catheter ablation

Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).

Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

left atrial appendage occlusion; radiofrequency ablation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation
2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
5. Provide informed consent to participate in the study;
6. Between 18-90 years

Exclusion Criteria

1. myocardial infarction within 3 months
2. Stroke or systemic embolism within 3 months
3. Plan to receive heart transplantation;
4. Life expectancy less than 1 year;
5. Severe bleeding diseases that cannot be treated with short-term anticoagulants;
6. With left atrial or left atrial appendage thrombus;
7. With uncontrolled malignant tumor ;
8. Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr \<50%);
9. Women who are pregnant, or breastfeeding.
10. Other conditions not suitable to the combined procedure.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes