Biventricular Alternative Pacing

Atrioventricular Block Clinical Trial

— BETTER  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00559143
• Other study ID #: 1111 Version 1.0- 01/May/2007
• Status: Withdrawn
• Phase: Phase 4
• First received: November 15, 2007
• Last updated: June 7, 2011
• Start date: November 2007
• Est. completion date: July 2011

Study information

• Verified date: June 2011
• Source: Medtronic Hellas Medical Devices ?EE
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 38
• Est. completion date: July 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrioventricular Block

Intervention

Other:
• 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

Locations

Country	Name	City	State
Greece	University Hospital of Crete	Heraklion	Crete

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Hellas Medical Devices ?EE

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in End Diastolic Diameter of Left Ventricle with the two different ways of pacing (DDD(R)-RV & DDD(R)-BiV)		two years	No
Secondary	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	No
Secondary	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	No