Back to resultsThe Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Primary Purpose
Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
left bundle branch area pacing
right ventricular pacing
Sponsored by
About this trial
This is an interventional treatment trial for Left Bundle Branch Area Pacing
Eligibility Criteria
Inclusion Criteria: Adult patients aged 18-85; AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms; Signed informed consent; Exclusion Criteria: Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%); Patients with the history of atrial fibrillation; Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons; Pacemaker replacement without new implanted ventricular electrodes; Surgery is required within 1 year due to severe structural heart disease; Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc); AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.
Sites / Locations
- Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
left bundle branch area pacing
right ventricular pacing
Arm Description
Outcomes
Primary Outcome Measures
the incidence of new-onset atrial fibrillation
Secondary Outcome Measures
all-cause mortality
hospitalization for heart failure
an device upgrade for heart failure
alteration of quality of life score
Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography
pacemaker-associated cardiomyopathy
Full Information
NCT ID
NCT06023784
First Posted
August 24, 2023
Last Updated
September 3, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06023784
Brief Title
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
Official Title
The Impact of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Bundle Branch Area Pacing, Right Ventricular Pacing, Atrioventricular Block, Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
530 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
left bundle branch area pacing
Arm Type
Experimental
Arm Title
right ventricular pacing
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
left bundle branch area pacing
Intervention Description
Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.
Intervention Type
Procedure
Intervention Name(s)
right ventricular pacing
Intervention Description
Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.
Primary Outcome Measure Information:
Title
the incidence of new-onset atrial fibrillation
Time Frame
within two years after device implantation
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
within two years after device implantation
Title
hospitalization for heart failure
Time Frame
within two years after device implantation
Title
an device upgrade for heart failure
Time Frame
within two years after device implantation
Title
alteration of quality of life score
Time Frame
within two years after device implantation
Title
Improvement of left ventricular, right ventricular and left atrial function measured by echocardiography
Time Frame
within two years after device implantation
Title
pacemaker-associated cardiomyopathy
Time Frame
within two years after device implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients aged 18-85;
AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d) symptomatic first degree AV block and PR interval on ECG > 300ms;
Signed informed consent;
Exclusion Criteria:
Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
Patients with the history of atrial fibrillation;
Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
Pacemaker replacement without new implanted ventricular electrodes;
Surgery is required within 1 year due to severe structural heart disease;
Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc);
AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deyan Yang, PhD.
Phone
+86 (010)69155068
Email
swallow_sums@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taibo Chen, PhD.
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taibo Chen, PhD.
Phone
+86 (010)69155068
First Name & Middle Initial & Last Name & Degree
Deyan Yang, PhD.
Phone
+86 (010)69155068
Email
swallow_sums@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
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