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: December 12, 2007
Last verified: December 2007
  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:


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
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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: 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: December 12, 2007
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Bradycardia
Sick Sinus Syndrome
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arrhythmia, Sinus

ClinicalTrials.gov processed this record on September 16, 2014