Biventricular Alternative Pacing (BETTER)

Medtronic Hellas Medical Devices ΑEE

Status and phase

Withdrawn

Phase 4

Conditions

Atrioventricular Block

Treatments

Other: Biventricular Pacing (DDD(R)- BiV)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559143

1111 Version 1.0- 01/May/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.