Biventricular Alternative Pacing

Medtronic Hellas Medical Devices ΑEE38 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atrioventricular Block

Interventions

Biventricular Pacing (DDD(R)- BiV)OTHER

Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Hospital of Crete

Heraklion, Crete, Greece

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.

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

Data from ClinicalTrials.gov

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