Biventricular Alternative Pacing

Study Overview
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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.

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.

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

Conditions
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Atrioventricular Block

Intervention / Treatment
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* Other: Biventricular Pacing (DDD(R)- BiV)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>DDD(R)-RV pacing | Other: Biventricular Pacing (DDD(R)- BiV)<br>* Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV<br>|
| Experimental: 2<br>DDD(R)- BIV pacing | Other: Biventricular Pacing (DDD(R)- BiV)<br>* Subjects indicated for DDD(R) pacing due to AV conduction disturbances and preserved LV function will receive biventricular pacing DDD(R)- BiV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AV conduction disturbances, LV function, Biventricular Pacing, Conductance Catheters