Clinical Trial: Left Ventricular Pacing to Avoid Cardiac Enlargement Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Seoul National University Hospital

Current Primary Outcome: Left ventricular ejection fraction (%) at 12 months [ Time Frame: 12 months ]

Measured by modified Simpson's method


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Left ventricular end-systolic volume (ml) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson method
  • Left ventricular end-diastolic volume (ml) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson method
  • NYHA functional class [ Time Frame: 12 months ]
  • Functional capacity [ Time Frame: 12 months ]
    measured by treadmill test
  • Quality of life [ Time Frame: 12 months ]
    measured by SF-36v2
  • NT-proBNP [ Time Frame: 12 months ]
    plasma level


Original Secondary Outcome:

  • Left ventricular end-systolic volume (ml) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson method
  • Left ventricular end-diastolic volume (ml) at 12 months [ Time Frame: 12 months ]
    Measured by modified Simpson method
  • Maximal oxygen uptake (ml/kg min) at 12 months [ Time Frame: 12 months ]
    Measured by exercise cardiopulmonary test


Information By: Seoul National University Hospital

Dates:
Date Received: February 19, 2011
Date Started: April 2010
Date Completion: December 2019
Last Updated: November 17, 2014
Last Verified: November 2014