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LBBP in CRT non-response patients

Multicenter, prospective efficacy and safety of left bundle branch regional pacing in patients with chronic heart failure of CRT nonresponse

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028131
Enrollment
Unknown
Registered
2019-12-13
Start date
2019-12-20
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Heart Failure

Interventions

experimental group:left bundle branch (LBB) regional pacing
control group:N/A

Sponsors

Department of Cardiology, Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Sign informed consent form of patients; 2. Aged over 18 years; 3. Expected lifetime greater than 1 year; 4. Sinus rhythm or atrial fibrillation with slow ventricular rate (VP > 90%); 5. The first time that the battery of CRT-P or CRT-D pulse generator is replaced due to exhaustion or has been implanted into CRT-P or CRT-D for more than 1 year, CRT was still unresponsive after chemotherapy and program control optimization (LVEF absolute value increased < 5% or relative value increased < 15%); 6. The residential area is relatively stable, which can meet the follow-up requirements during the clinical study.

Exclusion criteria

Exclusion criteria: 1. Women of childbearing age who are pregnant or intend to be pregnant during the study; 2. Other clinical studies that may affect the purpose of this study have been registered; 3. Patients with right ventricular mechanical valve; 4. Patients undergoing heart transplantation or waiting for heart transplantation; 5. Patients with valvular heart disease (such as valvular atrial fibrillation, severe regurgitation); 6. Within 30 days before joining the group, serum creatine level > 2.5mg/dl or > 275umol / L, Patients with severe renal insufficiency (GFR <= 30 ml / min / 1.72 m2); 7. There were more than three times of the upper limit of normal liver function in the five items of liver function within 30 days before admission; 8. Patients with severe anemia whose hemoglobin is less than 10.0g/dl within 30 days before admission; 9. The secondary cardiomyopathy, such as amyloidosis, sarcoidosis, hemochromatosis, glycogen accumulation and so on, affect the research results disease.

Design outcomes

Primary

MeasureTime frame
Echocardiographic;renal function;

Secondary

MeasureTime frame
cTNT;cTNT;NT-proBNP;NYHA;6MWD;

Countries

China

Contacts

Public ContactSu Yangang

Department of Cardiology, Zhongshan Hospital Affiliated to Fudan University

su.yangang@zs-hospital.sh.cn+86 13788905096

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026