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

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ClinicalTrials.gov Identifier: NCT00180557
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 17, 2015
Sponsor:
Information provided by:
Guidant Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Bradycardia Heart Block Sick Sinus Syndrome Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter
Study Start Date : September 2003
Actual Study Completion Date : May 2007

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. QRS width
  2. Ejection fraction
  3. NYHA class

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180557


Locations
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Austria
Krankenhaus der barmherzigen Schwestern
Ried im Innkreis, Austria
Sponsors and Collaborators
Guidant Corporation
Investigators
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Principal Investigator: C Nimeth, MD Krankenhaus der barmherzigen Schwestern Ried im Innkreis
More Information
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Responsible Party: Rainer Habeler, Guidant Austria
ClinicalTrials.gov Identifier: NCT00180557     History of Changes
Other Study ID Numbers: Austria Study v. 1.2
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: December 2007
Additional relevant MeSH terms:
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Bradycardia
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus
Cardiac Conduction System Disease