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Left bundle branch pacing for heart failure patients with mildly reduced ejection fraction with complete left bundle branch block: a pilot randomized controlled study

Left bundle branch pacing for heart failure patients with mildly reduced ejection fraction with complete left bundle branch block: a pilot randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107997
Enrollment
Unknown
Registered
2025-08-22
Start date
2025-09-20
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

heart failure with mildly reduced ejection fraction (HFmrEF) and left bundle branch block (LBBB)

Interventions

interventional group:Left Bundle Branch Pacing Implantation

Sponsors

The Second Affiliated Hospital of Army Medical University (Xinqiao Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: age 18-80 2: Non-ischemic dilated cardiomyopathy, NYHA II - IV, left ventricular ejection fraction (LVEF) 41% - 49% 3: Sinus rhythm, and the electrocardiogram meets the diagnostic criteria for LBBB (Strauss criteria): (1) The duration of the QRS complex is >=140 ms (in men) or >=130 ms (in women); (2) Leads V1 and V2 show a QS or rS pattern, with the amplitude of the r wave <1 mm; (3) There are notches in the QRS complex in at least two of the leads V1, V2, V5, V6, I, and avL. 4: Receive guideline-directed medical therapy (GDMT) for at least 3 months. 5: Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1: Previous implantation or need for implantation of a permanent artificial cardiac pacemaker 2: Need for implantation of a cardioverter-defibrillator 3: After tricuspid valve replacement with a mechanical valve 4: History of myocardial infarction 5: History of coronary artery bypass grafting or coronary intervention 6: Presence of permanent atrial arrhythmias, including persistent atrial fibrillation, atrial flutter, and atrial tachycardia 7: Severe valvular disease with indications for interventional treatment 8: Restrictive cardiomyopathy 9: Severe hepatic or renal insufficiency 10: Life expectancy of less than 1 year 11: Pregnancy

Design outcomes

Primary

MeasureTime frame
LVEF;

Secondary

MeasureTime frame
LVEDD/LVEDV;LVESD/LVESV;The NYHA Functional Classification;Six Minute Walk Test;NT-proBNP;Major Adverse Cardiovascular Events (Heart Failure Readmission andAll-Cause Mortality);

Countries

China

Contacts

Public ContactZhexue Qin

Department of Cardiology, Xiaoqiao Hospital, Chongqing, China

zhexueqin@126.com+86 158 2381 0730

Outcome results

None listed

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