- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302717
Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)
Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Seil Oh, MD, PhD
- Phone Number: 82-2-2072-2088
- Email: seil@snu.ac.kr
Study Contact Backup
- Name: Si-Hyuck Kang, MD
- Phone Number: 82-2-2072-3757
- Email: eandp303@gmail.com
Study Locations
-
-
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Seongnam, Korea, Republic of, 464-707
- Seoul National University Bundang Hospital
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Right ventricular pacing
|
The right ventricular lead are positioned at the right ventricular apex.
|
Experimental: Left ventricular pacing
|
The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left ventricular ejection fraction (%) at 12 months
Time Frame: 12 months
|
Measured by modified Simpson's method
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left ventricular end-systolic volume (ml) at 12 months
Time Frame: 12 months
|
Measured by modified Simpson method
|
12 months
|
Left ventricular end-diastolic volume (ml) at 12 months
Time Frame: 12 months
|
Measured by modified Simpson method
|
12 months
|
NYHA functional class
Time Frame: 12 months
|
12 months
|
|
Functional capacity
Time Frame: 12 months
|
measured by treadmill test
|
12 months
|
NT-proBNP
Time Frame: 12 months
|
plasma level
|
12 months
|
Collaborators and Investigators
Investigators
- Study Chair: Seil Oh, MD, PhD, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LVPACE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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