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Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)

This study is currently recruiting participants.
Verified February 2011 by Seoul National University Hospital
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01302717
First received: February 19, 2011
Last updated: February 23, 2011
Last verified: February 2011
History of Changes
  Purpose

In this study, the investigators examined 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.


Condition Intervention
Complete Atrioventricular Block
Sick Sinus Syndrome
 Device: LV pacing
Device: RV pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in Bradycardia Patients

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Left ventricular ejection fraction (%) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by modified Simpson's method


Secondary Outcome Measures:
  • Left ventricular end-systolic volume (ml) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by modified Simpson method

  • Left ventricular end-diastolic volume (ml) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by modified Simpson method

  • Maximal oxygen uptake (ml/kg min) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measured by exercise cardiopulmonary test


Estimated Enrollment: 98
Study Start Date: April 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

The primary end points are the left ventricular ejection fraction at 12 months. The secondary end points are the left ventricular systolic end-systolic and -diastolic volume at 12 months and maximal oxygen uptake at 12 months.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sinus-node dysfunction
  • Bradycardia due to advanced atrioventricular block

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302717

Contacts
Contact: Seil Oh, MD, PhD 82-2-2072-2088 seil@snu.ac.kr
Contact: Il-Young Oh, MD 82-31-787-7056 spy510@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Not yet recruiting
Seongnam, Korea, Republic of, 464-707
Contact: Il-Young Oh, MD     82-31-787-7056     spy510@snu.ac.kr    
Principal Investigator: Il-Young Oh, MD            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Seil Oh, MD, PhD     82-2-2072-2088     seil@snu.ac.kr    
Contact: Eue-Keun Choi, MD, PhD     82-2-2072-0688     choiek417@gmail.com    
Principal Investigator: Seil Oh, MD, PhD            
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Seil Oh, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seil Oh / Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01302717     History of Changes
Other Study ID Numbers: LVPACE
Study First Received: February 19, 2011
Last Updated: February 23, 2011
Health Authority: Korea, Republic of: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Left ventricular pacing

Additional relevant MeSH terms:
Atrioventricular Block
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus

ClinicalTrials.gov processed this record on May 19, 2013