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

Bradycardia Clinical Trial

Official title:

Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180557
• Other study ID #: Austria Study v. 1.2
• 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
• 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

• Bradycardia
• Heart Block
• Sick Sinus Syndrome

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