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Effect of Bachmann Bundle Pacing on Postoperative Atrial Fibrillation in Participants With Sick Sinus Syndrome: A Multicenter Randomized Controlled Trial

Effect of Bachmann Bundle Pacing on Postoperative Atrial Fibrillation in Participants With Sick Sinus Syndrome: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101973
Enrollment
Unknown
Registered
2025-05-06
Start date
2025-05-08
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sick Sinus Syndrome

Interventions

BBP Group:Bachmann Bundle Pacing
RAAP Group:Right Atrial Appendage Pacing

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Diagnosis of sick sinus syndrome (SSS); 3. Presence of any of the following conditions with a plan for first-time pacemaker implantation: (1). Symptomatic bradycardia (e.g., syncope, dizziness, fatigue) with symptoms attributable to bradycardia; (2). Bradycardia-tachycardia syndrome: characterized by predominant bradycardia with episodes of atrial tachyarrhythmias; (3). Exercise-induced symptoms, particularly in participants with chronotropic incompetence (i.e., inability to appropriately increase heart rate during exercise); (4). Asymptomatic participants with documented sinus arrest > 6 seconds; 4. Willingness to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Persistent atrial fibrillation/atrial flutter lasting more than 7 days, or permanent atrial fibrillation/atrial flutter; 2. Arrhythmias other than paroxysmal atrial fibrillation (lasting less than 7 days) and sick sinus syndrome; 3. Use of antiarrhythmic drugs before pacemaker implantation; 4. New York Heart Association (NYHA) functional class III or IV; 5. Congenital heart disease; 6. Severe valvular regurgitation, including severe tricuspid regurgitation, mitral regurgitation, pulmonary valve regurgitation, or aortic regurgitation; 7. Cardiomyopathy; 8. Cardiac surgeries involving cardiopulmonary bypass that remove the atrial appendage or affect atrial structure, including coronary artery bypass grafting, valve surgery, surgery for congenital heart disease, cardiac tumor surgery, heart transplantation, etc.; 9. History of atrioventricular node ablation; 10. Severe renal disease or other systemic diseases; 11. Within three months after angina or acute myocardial infarction; 12. Other conditions deemed inappropriate for inclusion by the investigators.

Design outcomes

Primary

MeasureTime frame
Atrial fibrillation episodes (duration >=6 minutes);

Secondary

MeasureTime frame
Atrial fibrillation episodes (duration >=6 hours);Atrial fibrillation episodes (duration >=24 hours);Atrial fibrillation burden;Incidence of cerebral embolism;All-cause mortality;Cardiovascular mortality;Health-related quality of life;

Countries

China

Contacts

Public ContactYongquan Wu

Beijing Anzhen Hospital, Capital Medical University

wuyongquan67@163.com+86 138 1075 1596

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026