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Left Ventricular Pacing to Avoid Cardiac Enlargement Study (LVPACE)

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ClinicalTrials.gov Identifier: NCT01302717
Recruitment Status : Recruiting
First Posted : February 24, 2011
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Seil Oh, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Complete AV Block Sick Sinus Syndrome Device: LV pacing Device: RV pacing Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Left Ventricular Pacing on Left Ventricular Systolic Function in High-risk Bradycardia Patients
Study Start Date : April 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Left ventricular ejection fraction (%) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson's method


Secondary Outcome Measures :
  1. Left ventricular end-systolic volume (ml) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson method

  2. Left ventricular end-diastolic volume (ml) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson method

  3. NYHA functional class [ Time Frame: 12 months ]
  4. Functional capacity [ Time Frame: 12 months ]
    measured by treadmill test

  5. Quality of life [ Time Frame: 12 months ]
    measured by SF-36v2

  6. NT-proBNP [ Time Frame: 12 months ]
    plasma level



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Seil Oh, Dr., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01302717     History of Changes
Other Study ID Numbers: LVPACE
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Seil Oh, Seoul National University Hospital:
Left ventricular pacing

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