Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)

Seoul National University

Status

Withdrawn

Conditions

Complete AV Block

Sick Sinus Syndrome

Treatments

Device: LV pacing

Device: RV pacing

Study type

Interventional

Funder types

Other

Identifiers

NCT01302717

LVPACE

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

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