NCT00559143WithdrawnPhase 4
Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function
Medtronic Hellas Medical Devices ΑEE2 sites in 1 country38 target enrollmentStarted: November 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
Study Overview
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 Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total).
- •Physiologic or mildly affected systolic function of left ventricle, LVEF> 40%.
- •Subject is willing and able to comply with the Clinical Investigational Plan and to remain available for follow-up visits, through study closure.
- •Subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study Informed Consent.
Exclusion Criteria
- •Subjects with classic indication for Biventricular Pacing - (European Guidelines 2007).
- •Permanent atrial fibrillation.
- •Cardiovascular surgery within the last three months prior to enrollment.
- •Myocardial infarction within the last three months prior to enrollment.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Tolerance in the cardiopulmonary stress test, quality of life, LV function and changes of BNP, TNF, interleukin-6, interleukin-12 and oxidant stress.(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.(two years)
Investigators
Study Sites (2)
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