Austria Study - Analysis of Difference Between Active and Passive Fixation Leads

This study has been completed.

First Received: September 15, 2005 Last Updated: December 12, 2007 History of Changes

Sponsor:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00180557

Purpose

In this study the difference between screw in leads actively fixed in the septum and tined leads passively fixed in the apex concerning electrical parameters and implantation time will be evaluated. In addition the influence of the stimulation location by type of lead on QRS width, ejection fraction and NYHA class will be evaluated using and electrocardiogram and echocardiogram.

Condition	Intervention	Phase
Bradycardia Heart Block Sick Sinus Syndrome	Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Analyse Der Unterschiede Zwischen Aktiv-Fixierenden Und Passiv-Fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

QRS width
Ejection fraction
NYHA class

Enrollment:	120
Study Start Date:	September 2003
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age < 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient

Exclusion Criteria:

Live expectancy < 6 months, pregnancy or women without contraception in birth bearing age, inability or refusal to sign consent form, simultaneous participation in another clinical trial, contraindication for any procedure required during pacemaker implantation, patients who need other pacemaker systems including pacing leads than those required by the protocol, heart failure (LVEF <35%, QRS-Width>150ms), functional (rate dependent) bundle branch bloc

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180557

Locations

Austria
Krankenhaus der barmherzigen Schwestern
Ried im Innkreis, Austria

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:

C Nimeth, MD

Krankenhaus der barmherzigen Schwestern Ried im Innkreis

More Information

No publications provided

Responsible Party:	Guidant Austria ( Rainer Habeler )
Study ID Numbers:	Austria Study v. 1.2
Study First Received:	September 15, 2005
Last Updated:	December 12, 2007
ClinicalTrials.gov Identifier:	NCT00180557 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:

Disease
Pathologic Processes
Heart Diseases
Arrhythmia, Sinus
Syndrome

Heart Block
Bradycardia
Cardiovascular Diseases
Sick Sinus Syndrome
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010