Left Ventricular Pacing to Avoid Cardiac Enlargement Study

Sick Sinus Syndrome Clinical Trial

— LVPACE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01302717
• Other study ID #: LVPACE
• Status: Withdrawn
• Phase: N/A
• Start date: April 2010
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete AV Block
• Sick Sinus Syndrome

Intervention

Device:
• LV pacing
The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
• RV pacing
The right ventricular lead are positioned at the right ventricular apex.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (%) at 12 months	Measured by modified Simpson's method	12 months
Secondary	Left ventricular end-systolic volume (ml) at 12 months	Measured by modified Simpson method	12 months
Secondary	Left ventricular end-diastolic volume (ml) at 12 months	Measured by modified Simpson method	12 months
Secondary	NYHA functional class		12 months
Secondary	Functional capacity	measured by treadmill test	12 months
Secondary	NT-proBNP	plasma level	12 months