Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREleft 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.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death | long-term after the procedure. | all-cause death |
| stroke/TIA/systemic embolism | long-term after the procedure. | The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis. |
| Major bleeding | long-term after the procedure. | The incidence of major bleeding in the participants will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure rehospitalization | after the procedure. | acute heart failure leading to hospitalization |
| maintenance of sinus rhythm | after the procedure outside the 3-month blanking period | This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias. |
| procedure-related complications | after the procedure. | These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation effects on quality-of-life (AFEQT) scores | at baseline and after the procedure | At baseline and at the 1-year follow-up visit, patients were required to complete a 20-item questionnaire based on the AF effects on quality-of-life (QoL) (AFEQT, http://www.afeqt.org) measure. The 20-item AFEQT survey evaluated 4 domains regarding the QoL assessment and the perception of treatment, i.e., symptoms, daily activities, treatment-related concerns, and treatment satisfaction. The first three domains constituted the global score. The scores of each individual domain and the global score ranged between 0 and 100, with 100 representing the best health status and 0 being the worst health status possible. A validated culturally and linguistically translated version of the AFEQT for China was used. |
Countries
China
Contacts
Primary ContactMu Chen, Dr.
Outcome results
None listed