Biventricular Alternative Pacing

Phase 4

Withdrawn

• Conditions: Atrioventricular Block
• Interventions: Other: Biventricular Pacing (DDD(R)- BiV)

• Registration Number: NCT00559143
• Lead Sponsor: Medtronic Hellas Medical Devices ΑEE

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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2009-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Biventricular Pacing (DDD(R)- BiV)	DDD(R)- BIV pacing
1	Biventricular Pacing (DDD(R)- BiV)	DDD(R)-RV pacing

Primary Outcome Measures

Name	Time	Method
Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)	two years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece