Tachycardia-bradycardia syndrome
Conditions
Interventions
Experimental group:Catheter radiofrequency ablation
Control group:Pacemaker implantation
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 18–75 years (inclusive, calculated on the date of signing the informed consent), both genders; 2.The study participant is diagnosed with tachycardia-bradycardia syndrome (i.e., "tachy-brady syndrome") according to the 2024 ESC Guidelines for the Management of Atrial Fibrillation: paroxysmal atrial fibrillation, atrial flutter, or atrial tachycardia, followed by sinoatrial block or sinus pause upon termination, leading to Stokes-Adams attacks; 3.Meeting indications for both catheter radiofrequency ablation and pacemaker implantation; 4.The study participant is able to comply with scheduled follow-up visits as arranged by the investigator, voluntarily participates, and signs the informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants had previously undergone catheter radiofrequency ablation for atrial fibrillation, cardiac surgical maze surgery, or pacemaker implantation; 2. Persistent atrial fibrillation or atrial flutter; 3. Those with conduction system diseases such as atrioventricular block, bundle branch block, or intraventricular block; 4. Patients who underwent percutaneous coronary intervention or coronary artery bypass surgery within 3 months; 5. Sinus node block or sinus arrest is not related to paroxysmal atrial fibrillation, atrial flutter, or atrial tachycardia episodes; 6. Those with a history of cerebrovascular disease within the last 3 months; 7. Having reversible causes that can lead to atrial fibrillation, including thyroid diseases, acute alcohol poisoning, recent major surgical procedures, or trauma; 8. Left atrial diameter (LAD) >= 55mm; or left atrial thrombosis; 9. Having severe liver dysfunction (ALT > 150U/L or AST > 150U/L), severe renal dysfunction (serum creatinine >= 178umol/L), severe coagulation dysfunction (any of the following 3 or more abnormalities: 1. Platelet 4g/L, in patients with leukemia and other malignant tumors 20mg/L, liver disease, leukemia FDP > 60mg/L, or D-dimer level elevated or positive. 4. PT shortened or prolonged by more than 3 seconds, liver disease, leukemia prolonged by more than 5 seconds, or APTT shortened or prolonged by more than 10 seconds). Or active bleeding, acute or severe systemic infection, etc.; 10. Expected lifespan < 12 months, such as in the terminal stage of malignant tumors; 11. Participants who had participated in other clinical studies within 3 months before enrollment; 12. According to the investigator's judgment, those who are considered not suitable for this clinical study (such as not meeting the most beneficial treatment for patients, patient compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite endpoint event was composed of cardiovascular rehospitalization and thromboembolic events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Feeling dizzy again, experiencing blackness and fainting;Health-related quality of life;All-cause mortality;Cardiovascular death ;All-cause hospitalization (TP);Cardiovascular hospitalization ;Hospitalization for acute thromboembolic events;Disabling stroke;Atrial fibrillation recurrence or progression ;Hospitalization for heart failure;Crossover rate between the two groups; | — |
Countries
China
Contacts
Public ContactYunlong Xia
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed