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A randomized controlled study on the effects of left bundle branch region pacing (LBBAP) under different programmed modes on left atrial volume and atrial high-frequency events in patients with sick sinus syndrome

A Randomized Controlled Study on the Effects of LBBAP Under Different Programming Modes on Left Atrial Volume and Atrial High-Rate Events in Patients with Sick Sinus Syndrome - LBBAP-AV RCT

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118813
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-13
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Sick Sinus Syndrome

Interventions

Fixed Optimized AV Interval Group:Disable minimization of ventricular pacing function, fixed pacing AV interval at 150ms, sensing AV interval at 120ms
Minimized Ventricular Pacing Group:Enable minimization of ventricular pacing function (MVP/VIP, etc.), set pacing AV interval at 200ms, sensing AV interval at 150ms

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Sick sinus syndrome with successful LBBAP implantation; 2. Paced QRS duration < 130 ms; 3. DDD pacing mode; 4. Age 18–80 years; 5. Willing to participate in the clinical trial and signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. Third-degree or high-grade atrioventricular block, or first-degree AV block with PR interval > 300 ms; 2. Class I or II indication for CRT; 3. Persistent atrial fibrillation; 4. LVEF < 50%; 5. Severe coronary artery disease, valvular heart disease, or congenital heart disease; 6. Life expectancy < 12 months.

Design outcomes

Primary

MeasureTime frame
Change in left atrial volume (LAV) at 12 months (?LAV = LAV12m ? LAV0m);Safety outcomes (including device-related discomfort/symptoms, device and lead-related abnormalities, arrhythmias and rhythm events, major clinical events);

Secondary

MeasureTime frame
Incidence of atrial high-rate episodes (AHRE), including atrial fibrillation, atrial flutter, and atrial tachycardia;Atrial fibrillation burden;

Countries

China

Contacts

Public ContactJiang Zhixin

The First Affiliated Hospital with Nanjing Medical University

jiangzx68az@gmail.com+86 139 1383 2207

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026