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

This study has been completed.

Sponsor:

Information provided by:

Guidant Corporation

ClinicalTrials.gov Identifier:

NCT00180557

First received: September 15, 2005

Last updated: March 10, 2015

Last verified: December 2007

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: progressive familial heart block sick sinus 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

Arms	Assigned Interventions
Experimental: Active fixation lead Active fixation lead was implanted	Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
Active Comparator: Passive fixation lead Passive fixation lead was implanted	Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Rainer Habeler, Guidant Austria
ClinicalTrials.gov Identifier:	NCT00180557 History of Changes
Other Study ID Numbers:	Austria Study v. 1.2
Study First Received:	September 15, 2005
Last Updated:	March 10, 2015
Health Authority:	Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:


Bradycardia Heart Block Sick Sinus Syndrome Arrhythmias, Cardiac	Heart Diseases Cardiovascular Diseases Pathologic Processes Arrhythmia, Sinus

ClinicalTrials.gov processed this record on September 28, 2016

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