Clinical trial NCT03788941: Left Atrial Appendage Closure in Combination With Catheter Ablation
Official title: The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: stroke/TIA/systemic embolism
timeFrame: long-term after the procedure.
measure: Major bleeding
timeFrame: long-term after the procedure.
measure: Death
timeFrame: long-term after the procedure.
Secondary outcomes:
measure: maintenance of sinus rhythm
timeFrame: after the procedure outside the 3-month blanking period
measure: procedure-related complications
timeFrame: after the procedure.
measure: Heart failure rehospitalization
timeFrame: after the procedure.
Other outcomes:
measure: Atrial fibrillation effects on quality-of-life (AFEQT) scores
timeFrame: at baseline and after the procedure
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiaotong University School of Medicine
name: Yi-Gang Li, Dr.
role: PRINCIPAL_INVESTIGATOR
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