An interventional study of LV pacing and RV pacing in Complete AV Block and Sick Sinus Syndrome, sponsored by Seoul National University Hospital. Withdrawn at 2 sites in Korea, Republic of. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
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.
89 studies on the registry are indexed under Sick Sinus Syndrome; 17 are open to participants now.
Browse Sick Sinus Syndrome studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Device: RV pacing
Device: LV pacing
The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
The right ventricular lead are positioned at the right ventricular apex.
Left ventricular ejection fraction (%) at 12 months
Measured by modified Simpson's method
Time frame: 12 months
Left ventricular end-systolic volume (ml) at 12 months
Measured by modified Simpson method
Time frame: 12 months
Left ventricular end-diastolic volume (ml) at 12 months
Measured by modified Simpson method
Time frame: 12 months
NYHA functional class
Time frame: 12 months
Functional capacity
measured by treadmill test
Time frame: 12 months
NT-proBNP
plasma level
Time frame: 12 months
This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital