Biventricular Alternative Pacing - Full Text View

Sponsored by:	Medtronic Hellas Medical Devices ΑEE
Information provided by:	Medtronic Hellas Medical Devices ΑEE
ClinicalTrials.gov Identifier:	NCT00559143

Purpose

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.

Condition	Intervention	Phase
Atrioventricular Block	Other: Biventricular Pacing (DDD(R)- BiV)	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment, Efficacy Study
Official Title:	Better Pacing - Biventricular Pacing as Alternative Method in Patients With Disturbances of AV Conduction and Preserved LV Function

Further study details as provided by Medtronic Hellas Medical Devices ΑEE:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	38
Study Start Date:	November 2007
Estimated Study Completion Date:	July 2011

Arms	Assigned Interventions
1: Active Comparator DDD(R)-RV pacing	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
2: Experimental DDD(R)- BIV pacing	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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559143

Contacts

Contact: Emmanuel Simantirakis, MD

+30 2810 392632

esimant@hotmail.com

Locations

Greece, Crete
University Hospital of Crete	Recruiting
Heraklion, Crete, Greece, PO1352
Principal Investigator: Emmanuel Simantirakis, MD

Sponsors and Collaborators

Medtronic Hellas Medical Devices ΑEE

Investigators

Principal Investigator:	Emmanuel Simantirakis, MD	University Hospital of Crete
Study Chair:	Panagiotis Vardas, MD, Cardiology Professor	University Hospital of Crete

More Information

Responsible Party:	Medtronic Hellas Medical Devices ΑEE ( George Athanasiou/ Senior Field Clinical Research Specialist )
Study ID Numbers:	1111 Version 1.0- 01/May/2007
Study First Received:	November 15, 2007
Last Updated:	December 11, 2007
ClinicalTrials.gov Identifier:	NCT00559143
Health Authority:	Greece: Ethics Committee; Greece: National Organization of Medicines

Keywords provided by Medtronic Hellas Medical Devices ΑEE:

AV conduction disturbances
LV function
Biventricular Pacing
Conductance Catheters

Study placed in the following topic categories:

Heart Diseases
Heart Block
Atrioventricular Block
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009