Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy, Heart Failure
Conditions
Brief summary
The study was designed to compare the acute effects of left bundle branch pacing (LBBP) with biventricular pacing (BVP) in patients with left ventricular ejection fraction (LVEF) \<=35% with left bundle branch block (LBBB).
Detailed description
The metrics include electrocardiographic, echocardiographic and hemodynamic parameters to evaluate and compare LBBP with BVP for resynchronization therapy in patients with heart failure and LBBB.
Interventions
PROCEDUREleft bundle branch pacing
left bundle branch pacing
PROCEDUREbiventricular pacing
biventricular pacing
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* NYHA class II-IV; * LVEF \<=35%; * LBBB with QRS duration \>=130ms.
Exclusion criteria
* moderate-to-severe aortic stenosis; * frequent premature ventricular complexes; * significant peripheral vascular disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic parameter LV dP/dt(max) | 1 hour | LV dP/dt(max) will be obtained during implant procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electrical synchrony parameters including QRS duration and QRS area | 0.5 hour | Acquired from EP system during procedure |
| Mechanical parameters including Ts-SD and IVMD | 0.5 hour | Acquired by an echocardiologist during procedure |
Countries
China
Outcome results
None listed