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The feasibility and preliminary clinical evaluation of Bachman bundle area pacing using leadless atrial pacemakers

The feasibility and preliminary clinical evaluation of Bachman bundle area pacing using leadless atrial pacemakers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125279
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-05-25
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

sinus bradycardia

Interventions

Experimental group:BBaP using atrial LP

Sponsors

Shanghai Chest Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with sick sinus syndrome with clear indications for atrial pacing, in accordance with current clinical practice guidelines. 2. Aged between 18 and 80 years. 3. Meet the indications for leadless pacing, and the patient voluntarily chooses to undergo atrial leadless pacemaker implantation. 4. Understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. persistent AF/atrial flutter; 2. patients with severe structural heart disease or heart failure; 3. the expected survival time was less than 1 year; 4. pregnancy or planned pregnancy; 5. unsuitable anatomical or clinical conditions for leadless atrial pacemaker implantation; 6. Other clinical trials that may affect the purpose of this study have been registered.

Design outcomes

Primary

MeasureTime frame
Success rate of implantation of Bachmann's bundle area pacing;Pacing-related parameters;

Secondary

MeasureTime frame
P-wave ECG characteristics;Echo parameters;procedure -related complications;

Countries

China

Contacts

Public ContactLi Ruogu

Shanghai Chest Hospital

13564565961@163.com+86 180 1732 0201

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026