Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)

April 14, 2023 updated by: Seil Oh, Seoul National University Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 464-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Right ventricular pacing
Device: RV pacing
The right ventricular lead are positioned at the right ventricular apex.
Experimental: Left ventricular pacing
Device: LV pacing
The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (%) at 12 months
Time Frame: 12 months
Measured by modified Simpson's method
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Seil Oh, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

February 19, 2011

First Submitted That Met QC Criteria

February 23, 2011

First Posted (Estimate)

February 24, 2011

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVPACE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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