Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function

Medtronic Hellas Medical Devices ΑEE1 site in 1 country38 target enrollmentNovember 2007

ConditionsAtrioventricular Block

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atrioventricular Block
Sponsor: Medtronic Hellas Medical Devices ΑEE
Enrollment: 38
Locations: 1
Primary Endpoint: Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

July 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Medtronic Hellas Medical Devices ΑEE

Eligibility Criteria

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)