NCT01302717

Left Ventricular Pacing to Avoid Cardiac Enlargement Study

Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complete AV Block
• Sick Sinus Syndrome

Interventions

Type	Name	Description
DEVICE	LV pacing	The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
DEVICE	RV pacing	The right ventricular lead are positioned at the right ventricular apex.

Timeline

• Start date: 2010-04-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2011-02-24
• Last updated: 2023-04-18

Locations

2 sites across 1 country: South Korea