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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00180557
Other study ID # Austria Study v. 1.2
Secondary ID
Status Completed
Phase Phase 4
First received September 15, 2005
Last updated March 10, 2015
Start date September 2003
Est. completion date May 2007

Study information

Verified date December 2007
Source Guidant Corporation
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip


Locations

Country Name City State
Austria Krankenhaus der barmherzigen Schwestern Ried im Innkreis

Sponsors (1)

Lead Sponsor Collaborator
Guidant Corporation

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary QRS width
Primary Ejection fraction
Primary NYHA class
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