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

Condition(s) targeted: Bradycardia; Heart Block; Sick Sinus Syndrome

Intervention: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip (Device)

Phase: Phase 4

Status: Completed

Sponsored by: Guidant Corporation

Official(s) and/or principal investigator(s):
C Nimeth, MD, Principal Investigator, Affiliation: Krankenhaus der barmherzigen Schwestern Ried im Innkreis

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.

Official title: Analyse Der Unterschiede Zwischen Aktiv-Fixierenden Und Passiv-Fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

QRS width

Ejection fraction

NYHA class

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Krankenhaus der barmherzigen Schwestern, Ried im Innkreis, Austria

Starting date: September 2003
Ending date: May 2007
Last updated: December 12, 2007