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Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Seil Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01302717
First received: February 19, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Complete AV 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 High-risk Bradycardia Patients

Resource links provided by NLM:


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

  • NYHA functional class [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Functional capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measured by treadmill test

  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    measured by SF-36v2

  • NT-proBNP [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    plasma level


Estimated Enrollment: 98
Study Start Date: April 2010
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (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). 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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Si-Hyuck Kang, MD 82-2-2072-3757 eandp303@gmail.com

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, Dr., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01302717     History of Changes
Other Study ID Numbers: LVPACE
Study First Received: February 19, 2011
Last Updated: November 17, 2014
Health Authority: Korea, Republic of: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Left ventricular pacing

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

ClinicalTrials.gov processed this record on November 20, 2014