Atrial Fibrillation (AF)
Conditions
Keywords
pulsed field ablation, atrial fibrillation
Brief summary
Atrial fibrillation (AF) is one of the most concerning diseases in the field of cardiac arrhythmias. It is a type of rapid supraventricular arrhythmia characterized by rapid and disorganized contraction of the atria, which leads to ventricular rate disturbance, impaired cardiac function, and an increased risk of atrial mural thrombus formation. AF severely reduces patients' quality of life and can cause complications such as heart failure, stroke, and sudden death. Currently, the vast majority of AF episodes are triggered by pulmonary vein (PV) ectopic foci. Therefore, catheter ablation is the preferred treatment strategy, with pulmonary vein isolation (PVI) being the cornerstone procedure. However, a small proportion of patients may have non-PV triggers, particularly originating from the superior vena cava (SVC). Conventional radiofrequency ablation (RFA) for SVC isolation carries unpredictable risks, including damage to the sinus node and the phrenic nerve. Therefore, this study aims to investigate the impact of empirical SVC electrical isolation in addition to PVI on the success rate of AF ablation, using pulsed field ablation (PFA)-a non-thermal ablation modality with tissue selectivity and a favorable safety profile.
Interventions
PROCEDUREsuperior vena cava isolation plus pulmonary Vein isolation
Eligible patients with atrial fibrillation who are randomized to the experimental group will undergo superior vena cava (SVC) electrical isolation in addition to pulmonary vein isolation (PVI) during the pulsed field ablation procedure
PROCEDUREpulmonary vein isolation
Eligible patients with atrial fibrillation who are randomized to the control group will undergo pulmonary vein isolation (PVI) during the pulsed field ablation procedure
Sponsors
Qiang Hu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Patients with documented atrial fibrillation (AF), confirmed by at least one episode of AF recorded on a 12-lead surface electrocardiogram (ECG) or ambulatory ECG monitoring within the past 12 months; * Subjects who agree to undergo treatment for AF using a pulsed field ablation (PFA) system that is currently commercially available in China; * Patients who have shown an inadequate response to, or intolerance of, at least one class of antiarrhythmic drug therapy; * Subjects or their legally authorized representatives who have been informed of the nature of this study, have agreed to all terms and conditions of the study, and have provided written informed consent, and who are willing to complete all required clinical follow-up visits in accordance with the study protocol.
Exclusion criteria
* Prior surgical or catheter ablation for any type of cardiac arrhythmia; * AF secondary to electrolyte imbalance, valvular heart disease, thyroid disease, or other reversible causes; * Known requirement for ablation outside the pulmonary vein ostia or beyond the cavotricuspid isthmus; * Sinus node dysfunction or other indications for permanent pacemaker implantation; * Myocardial infarction, or prior coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within the past 6 months; * Left atrial anteroposterior diameter ≥ 50 mm; * Evidence of left atrial or left atrial appendage thrombus confirmed by transesophageal echocardiography (TEE) or left atrial computed tomography (CT) within 24 hours prior to the procedure; * Serum creatinine \> 2 times the upper limit of normal, or currently on dialysis; * History of prior cardiothoracic surgery; * History of permanent pacemaker implantation; * History of malignancy; * Long-term use of a central venous catheter; * Contraindications to anticoagulation therapy (including allergy to anticoagulants, thrombocytopenia, severe bleeding tendency, or coagulation disorders); * History of allergy to contrast; * Women who are pregnant, lactating, or who are unwilling to use adequate contraception during the study period; * Subjects or their legally authorized representatives who are unwilling to provide written informed consent; * Subjects who, for any reason, are unable to comply with the study protocol or complete all required clinical follow-up visits; * Subjects deemed by the investigator to be unsuitable for PFA treatment of AF.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the success rate of atrial fibrillation ablation | at 3 month | it is assessed by 7-day Holter monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the success rate of atrial fibrillation ablation | at 6 month and 12 month | it is assessed by 7-day Holter monitoring |
| 6-min walk distance | at 3 month, 6 month and 12 month | During the test, patients were asked to walk for 6 minutes on a long corridor with a length of 37.5 meters between the 2 marks |
| red blood cell count | at 3 month, 6 month and 12 month | It is obtained from the routine blood test. |
| hemoglobin | at 3 month, 6 month and 12 month | It is obtained from the routine blood test. |
| white blood cell count | at 3 month, 6 month and 12 month | It is obtained from the routine blood test. |
| platelet count | at 3 month, 6 month and 12 month | It is obtained from the routine blood test. |
| alanine aminotransferase | at 3 month, 6 month and 12 month | It is obtained from the liver function test. |
| aspartate aminotransferase | at 3 month, 6 month and 12 month | It is obtained from the liver function test. |
| creatinine | at 3 month, 6 month and 12 month | It is obtained from the renal function test |
| urea | at 3 month, 6 month and 12 month | It is obtained from the renal function test |
| estimated glomerular filtration rate | at 3 month, 6 month and 12 month | It is obtained from the renal function test |
| activated partial thromboplastin time | at 3 month, 6 month and 12 month | It is obtained from the coagulation function test |
| prothrombin time | at 3 month, 6 month and 12 month | It is obtained from the coagulation function test |
| international normalized ratio | at 3 month, 6 month and 12 month | It is obtained from the coagulation function test |
| B-type natriuretic peptide | at 3 month, 6 month and 12 month | It is obtained from a blood sample. |
| left ventricular end-systolic diameter | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| left ventricular end-diastolic diameter | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| left ventricular posterior wall thickness | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| interventricular septal thickness | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| left ventricular ejection fraction | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| E/A | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| E/e' | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| left atrial volume index | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| left atrial anteroposterior diameter | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| left atrial strain | at 3 month, 6 month and 12 month | it is measured by echocardiography |
| New York Heart Association class | at 3 month, 6 month and 12 month | The NYHA is measured by Classification of NYHA heart function |
| Atrial Fibrillation Effect on Quality of Life Questionnaire | at 3 month, 6 month and 12 month | AFEQT questionnaire was used to assess the quality of life of patients with atrial fibrillation. |
| Major adverse events | at 3 month, 6 month and 12 month | Major adverse events is a composite endpoint of death, stroke, and myocardial infarction. |
| readmission | at 3 month, 6 month and 12 month | Rehospitalization was indicated for atrial fibrillation. |
Countries
China
Contacts
CONTACTQiang Hu, Doctor
Outcome results
None listed