Clinical Trial: Biventricular Alternative Pacing
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
Brief Summary: Aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.
Detailed Summary: In this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. In all subjects a biventricular pacemaker will be implanted. Moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.
Sponsor: Medtronic Hellas Medical Devices ΑEE
Current Primary Outcome: Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV) [ Time Frame: two years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress. [ Time Frame: two years ]
- Assessment of the operation of Left Ventricle at the different pacing types using conductance catheters in a subgroup of patients that will perform a programmed coronary angiography due to investigation of possible coronary artery disease. [ Time Frame: two years ]
Original Secondary Outcome: Same as current
Information By: Medtronic Hellas Medical Devices ΑEE
Dates:
Date Received: November 15, 2007
Date Started: November 2007
Date Completion: July 2011
Last Updated: June 7, 2011
Last Verified: June 2011
