Acute Effects of LBBP Versus BVP for CRT
Primary Purpose
Heart Failure, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
left bundle branch pacing
biventricular pacing
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- 180 Fenglin Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Left bundle branch pacing
Biventricular pacing
Arm Description
Left bundle branch pacing
Biventricular pacing
Outcomes
Primary Outcome Measures
Hemodynamic parameter LV dP/dt(max)
LV dP/dt(max) will be obtained during implant procedure.
Secondary Outcome Measures
Electrical synchrony parameters including QRS duration and QRS area
Acquired from EP system during procedure
Mechanical parameters including Ts-SD and IVMD
Acquired by an echocardiologist during procedure
Full Information
NCT ID
NCT04505384
First Posted
July 31, 2020
Last Updated
January 19, 2022
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04505384
Brief Title
Acute Effects of LBBP Versus BVP for CRT
Official Title
Acute Effects of Left Bundle Branch Pacing Versus Biventricular Pacing for Cardiac Resynchronization Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiac Pacing, Artificial, Cardiac Resynchronization Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Left bundle branch pacing
Arm Type
Experimental
Arm Description
Left bundle branch pacing
Arm Title
Biventricular pacing
Arm Type
Active Comparator
Arm Description
Biventricular pacing
Intervention Type
Procedure
Intervention Name(s)
left bundle branch pacing
Intervention Description
left bundle branch pacing
Intervention Type
Procedure
Intervention Name(s)
biventricular pacing
Intervention Description
biventricular pacing
Primary Outcome Measure Information:
Title
Hemodynamic parameter LV dP/dt(max)
Description
LV dP/dt(max) will be obtained during implant procedure.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Electrical synchrony parameters including QRS duration and QRS area
Description
Acquired from EP system during procedure
Time Frame
0.5 hour
Title
Mechanical parameters including Ts-SD and IVMD
Description
Acquired by an echocardiologist during procedure
Time Frame
0.5 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yangang Su, MD
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36306335
Citation
Liang Y, Wang J, Gong X, Lu H, Yu Z, Zhang L, Li M, Pan L, Chen X, Cui J, Zhang W, Li R, Zhou X, Huang W, Su Y, Ge J. Left Bundle Branch Pacing Versus Biventricular Pacing for Acute Cardiac Resynchronization in Patients With Heart Failure. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e011181. doi: 10.1161/CIRCEP.122.011181. Epub 2022 Oct 28.
Results Reference
derived
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Acute Effects of LBBP Versus BVP for CRT
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