Left Ventricular Pacing to Avoid Cardiac Enlargement Study

NCT01302717 | Withdrawn

• 1 other identifier: LVPACE
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Complete AV Block; Sick Sinus Syndrome

Keywords

Left ventricular pacing

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (%) at 12 months

  Measured by modified Simpson's method

  12 months

Secondary Outcomes (5)

• Left ventricular end-systolic volume (ml) at 12 months

  12 months

• Left ventricular end-diastolic volume (ml) at 12 months

  12 months

• NYHA functional class

  12 months

• Functional capacity

  12 months

• NT-proBNP

  12 months

Study Arms (2)

Right ventricular pacing

ACTIVE COMPARATOR

Device: RV pacing

Left ventricular pacing

EXPERIMENTAL

Device: LV pacing

Interventions

LV pacing DEVICE

The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.

Left ventricular pacing

RV pacing DEVICE

The right ventricular lead are positioned at the right ventricular apex.

Right ventricular pacing

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sinus-node dysfunction or bradycardia due to advanced atrioventricular block
• Paced QRS duration ≥185 ms

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, 464-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seil Oh, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 19, 2011
• First Posted: February 24, 2011
• Study Start: April 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

KR (2)