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

This study has been completed.
Information provided by:
Guidant Corporation Identifier:
First received: September 15, 2005
Last updated: March 10, 2015
Last verified: December 2007
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
Heart Block
Sick Sinus Syndrome
Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00180557

Krankenhaus der barmherzigen Schwestern
Ried im Innkreis, Austria
Sponsors and Collaborators
Guidant Corporation
Principal Investigator: C Nimeth, MD Krankenhaus der barmherzigen Schwestern Ried im Innkreis
  More Information

Responsible Party: Rainer Habeler, Guidant Austria 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

Additional relevant MeSH terms:
Heart Block
Sick Sinus Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus processed this record on May 24, 2017