Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)
Primary Purpose
Complete AV Block, Sick Sinus Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LV pacing
RV pacing
Sponsored by
About this trial
This is an interventional treatment trial for Complete AV Block focused on measuring Left ventricular pacing
Eligibility Criteria
Inclusion Criteria:
- Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
- Paced QRS duration ≥185 ms
Exclusion Criteria:
- Left ventricular ejection fraction < 50 %
- Acute coronary syndrome
- If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
- if they had a life expectancy of less than 1 year
- if they had received a heart transplant
Sites / Locations
- Seoul National University Bundang Hospital
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Right ventricular pacing
Left ventricular pacing
Arm Description
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction (%) at 12 months
Measured by modified Simpson's method
Secondary Outcome Measures
Left ventricular end-systolic volume (ml) at 12 months
Measured by modified Simpson method
Left ventricular end-diastolic volume (ml) at 12 months
Measured by modified Simpson method
NYHA functional class
Functional capacity
measured by treadmill test
NT-proBNP
plasma level
Full Information
NCT ID
NCT01302717
First Posted
February 19, 2011
Last Updated
April 14, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01302717
Brief Title
Left Ventricular Pacing to Avoid Cardiac Enlargement Study
Acronym
LVPACE
Official Title
Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in enrollment
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, the investigators will examine whether left ventricular pacing is superior to right ventricular apical pacing in preventing deterioration of left ventricular systolic function and cardiac remodeling in patients with bradycardia with high risk for development of pacing-induced heart failure.
Detailed Description
In this prospective, we will randomly assign 98 patients who need permanent pacemaker due to complete atrioventricular block or sick sinus syndrome to receive left ventricular pacing (49 patients) or right ventricular apical pacing (49 patients). Patients will be paced with temporary pacemaker lead, and only those with paced QRS duration ≥185 ms will be enrolled.
The primary endpoint is left ventricular ejection fraction measured by modified Simpson method at 12 months. The secondary end points include left ventricular systolic end-systolic and diastolic volume, LV strain, NYHA functional class, exercise performance (using treadmill test), quality of life (using SF-36v2), NT-proBNP at 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete AV Block, Sick Sinus Syndrome
Keywords
Left ventricular pacing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right ventricular pacing
Arm Type
Active Comparator
Arm Title
Left ventricular pacing
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LV pacing
Intervention Description
The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
Intervention Type
Device
Intervention Name(s)
RV pacing
Intervention Description
The right ventricular lead are positioned at the right ventricular apex.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction (%) at 12 months
Description
Measured by modified Simpson's method
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Left ventricular end-systolic volume (ml) at 12 months
Description
Measured by modified Simpson method
Time Frame
12 months
Title
Left ventricular end-diastolic volume (ml) at 12 months
Description
Measured by modified Simpson method
Time Frame
12 months
Title
NYHA functional class
Time Frame
12 months
Title
Functional capacity
Description
measured by treadmill test
Time Frame
12 months
Title
NT-proBNP
Description
plasma level
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
Paced QRS duration ≥185 ms
Exclusion Criteria:
Left ventricular ejection fraction < 50 %
Acute coronary syndrome
If they had undergone percutaneous coronary intervention or coronary-artery bypass surgery within the previous 3 months
if they had a life expectancy of less than 1 year
if they had received a heart transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seil Oh, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
464-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
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Left Ventricular Pacing to Avoid Cardiac Enlargement Study
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