Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
Primary Purpose
Atrioventricular Block, Second and Third Degree, Heart Failure, Left Bundle Branch Pacing
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Left bundle branch pacing
Bi-ventricular pacing
Sponsored by
About this trial
This is an interventional treatment trial for Atrioventricular Block, Second and Third Degree focused on measuring pacing induced cardiomyopathy, heart failure, pacing, LBBP, BVP, RVP, conduction system pacing, cardiac Resynchronization Therapy, bradycardiac arrhythmia
Eligibility Criteria
Inclusion Criteria:
- Above 18 years old
- Agree to participate in trial and sign informed consent
- NYHA cardiac function class I-III
- LVEF<50%
- Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage >40%
- Patients who are willing to take the de-novo implant or device replacement or upgrade.
Exclusion Criteria:
- Life expectancy <1 year
- Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
- Acute myocardial infarction within 1 month
- Women of childbearing age who are pregnant or becoming pregnant during the study period
- Severe liver and kidney dysfunction2
- Have been enrolled in another clinical studies that may interferes with the current trial objectives
- Evidence of severe pulmonary hypertension (PASP>70mmHg)
- Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients.
- The investigator believes that subject's physical condition is not suitable for participation in the trial
Sites / Locations
- First Affliated Hospital, Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LBBP Treatment
BVP Treatment
Arm Description
Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device
Patients were performed bi-ventricular pacing by a CRT/CRTD device
Outcomes
Primary Outcome Measures
Change of LVEF
To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant.
Secondary Outcome Measures
Change of LVESV
To demonstrate and compare the LVESV at 12 month post-implant.
successful rate
To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.
mortality and heart failure hospitalization rate
To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant
occurrence of serious complication associated with LBBP procedure
To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant.
QRS width between LBBP and CRT
To characterize and compare the QRS width between LBBP and CRT treatment groups during the baseline, preoperative, postoperative and follow up visits within 3 months and 12 month post-implant.
incidence and severity of tricuspid regurgitation
To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant
Full Information
NCT ID
NCT05553626
First Posted
September 21, 2022
Last Updated
September 21, 2022
Sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Yunnan, Shanghai Zhongshan Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital of Nanchang University, Tianjin Chest Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Shanghai Chest Hospital, Medtronic (Shanghai) Management Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05553626
Brief Title
Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
Official Title
Safety and Effectiveness of Left Bundle Branch Pacing (LBBP) in Patients With Cardiac Dysfunction and AV Block
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Wenzhou Medical University
Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital, Sir Run Run Shaw Hospital, The First Affiliated Hospital of Dalian Medical University, Shanxi Cardiovascular Hospital, Shanghai 10th People's Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Yunnan, Shanghai Zhongshan Hospital, Shenzhen Sun Yat-sen Cardiovascular Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital of Nanchang University, Tianjin Chest Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Yan'an Affiliated Hospital of Kunming Medical University, Shanghai Chest Hospital, Medtronic (Shanghai) Management Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a multicenter, prospective, randomized study to assess if cardiac dysfunction patients with LVEF <50% and the estimated ventricular pacing percentage >40% with LBBP have the non-inferior safety and efficacy than CRT on patients' cardiac function and prognosis
Detailed Description
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, patients with cardiac dysfunction who met the enrollment criteria and will agree to participate in this trial will be 1:1 randomized to the LBBP group and the CRT group. Patients who were successfully implanted were enrolled for evaluation and follow-up. The primary end points of the study is the change of LVEF within 12 months post-implant in both LBBP Treatment Group and CRT Treatment Group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block, Second and Third Degree, Heart Failure, Left Bundle Branch Pacing
Keywords
pacing induced cardiomyopathy, heart failure, pacing, LBBP, BVP, RVP, conduction system pacing, cardiac Resynchronization Therapy, bradycardiac arrhythmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LBBP Treatment
Arm Type
Experimental
Arm Description
Patients were performed left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device
Arm Title
BVP Treatment
Arm Type
Active Comparator
Arm Description
Patients were performed bi-ventricular pacing by a CRT/CRTD device
Intervention Type
Device
Intervention Name(s)
Left bundle branch pacing
Intervention Description
Left bundle branch pacing by a single/dual chamber pacemaker or dual chamber ICD device through the pacing lead at left bundle branch region
Intervention Type
Device
Intervention Name(s)
Bi-ventricular pacing
Intervention Description
Bi-ventricular pacing by a CRT/CRTD device
Primary Outcome Measure Information:
Title
Change of LVEF
Description
To compare the effects of LBBP Treatment Group and CRT Treatment Group on target subjects by analyzing the LVEF within 12 months post-implant.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of LVESV
Description
To demonstrate and compare the LVESV at 12 month post-implant.
Time Frame
12 months
Title
successful rate
Description
To characterize the successful rate of LBBP Procedure and CRT Procedure among randomized patients' group.
Time Frame
12 months
Title
mortality and heart failure hospitalization rate
Description
To demonstrate and compare the mortality and heart failure hospitalization rate between LBBP and CRT treatment group 12 month post-implant
Time Frame
12 months
Title
occurrence of serious complication associated with LBBP procedure
Description
To characterize occurrence of serious complication associated with LBBP procedure within 12 month post-implant.
Time Frame
12 months
Title
QRS width between LBBP and CRT
Description
To characterize and compare the QRS width between LBBP and CRT treatment groups during the baseline, preoperative, postoperative and follow up visits within 3 months and 12 month post-implant.
Time Frame
12 months
Title
incidence and severity of tricuspid regurgitation
Description
To assess and compare the incidence and severity of tricuspid regurgitation between LBBP and CRT treatment groups within 12 month post-implant
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Above 18 years old
Agree to participate in trial and sign informed consent
NYHA cardiac function class I-III
LVEF<50%
Second or complete atrioventricular block with pacing indication or ventricular pacing dependent with ventricular pacing percentage >40%
Patients who are willing to take the de-novo implant or device replacement or upgrade.
Exclusion Criteria:
Life expectancy <1 year
Patients with severe tricuspid valvular disease1 or who have undergone mechanical valve or bioprosthetic valve surgery
Acute myocardial infarction within 1 month
Women of childbearing age who are pregnant or becoming pregnant during the study period
Severe liver and kidney dysfunction2
Have been enrolled in another clinical studies that may interferes with the current trial objectives
Evidence of severe pulmonary hypertension (PASP>70mmHg)
Evidence of hypertrophic cardiomyopathy which shall affect the prognosis of patients.
The investigator believes that subject's physical condition is not suitable for participation in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weijian Huang, MD
Phone
+86138-0669-1086
Email
weijianhuang69@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Su, MD
Phone
+86 137-3874-2616
Email
2512057600@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weijian Huang, MD
Organizational Affiliation
Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affliated Hospital, Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Effectiveness of Left Bundle Branch Pacing in Patients With Cardiac Dysfunction and AV Block
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