Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients|
- Left ventricular ejection fraction (%) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by modified Simpson's method
- Left ventricular end-systolic volume (ml) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by modified Simpson method
- Left ventricular end-diastolic volume (ml) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Measured by modified Simpson method
- NYHA functional class [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Functional capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]measured by treadmill test
- Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]measured by SF-36v2
- NT-proBNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]plasma level
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
|Active Comparator: Right ventricular pacing||
Device: RV pacing
The right ventricular lead are positioned at the right ventricular apex.
|Experimental: Left ventricular pacing||
Device: LV pacing
The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302717
|Contact: Seil Oh, MD, PhDfirstname.lastname@example.org|
|Contact: Si-Hyuck Kang, MDemail@example.com|
|Korea, Republic of|
|Seoul National University Bundang Hospital||Not yet recruiting|
|Seongnam, Korea, Republic of, 464-707|
|Contact: Il-Young Oh, MD 82-31-787-7056 firstname.lastname@example.org|
|Principal Investigator: Il-Young Oh, MD|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Seil Oh, MD, PhD 82-2-2072-2088 email@example.com|
|Contact: Eue-Keun Choi, MD, PhD 82-2-2072-0688 firstname.lastname@example.org|
|Principal Investigator: Seil Oh, MD, PhD|
|Study Chair:||Seil Oh, MD, PhD||Seoul National University Hospital|