Left Ventricular Pacing to Avoid Cardiac Enlargement Study

Not Applicable

Withdrawn

• Conditions: Sick Sinus Syndrome; Complete AV Block
• Interventions: Device: RV pacing; Device: LV pacing

• Registration Number: NCT01302717
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-02-19
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Right ventricular pacing	RV pacing	-
Left ventricular pacing	LV pacing	-

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (%) at 12 months	12 months	Measured by modified Simpson's method

Secondary Outcome Measures

Name	Time	Method
NYHA functional class	12 months
NT-proBNP	12 months	plasma level
Left ventricular end-systolic volume (ml) at 12 months	12 months	Measured by modified Simpson method
Functional capacity	12 months	measured by treadmill test
Left ventricular end-diastolic volume (ml) at 12 months	12 months	Measured by modified Simpson method

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of