Biventricular Alternative Pacing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrioventricular Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

DDD(R)-RV pacing

Group Type ACTIVE_COMPARATOR

Biventricular Pacing (DDD(R)- BiV)

Intervention Type OTHER

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

2

DDD(R)- BIV pacing

Group Type EXPERIMENTAL

Biventricular Pacing (DDD(R)- BiV)

Intervention Type OTHER

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

Interventions

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Biventricular Pacing (DDD(R)- BiV)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No