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

Guidant Corporation120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Bradycardia Heart Block Sick Sinus Syndrome

Interventions

Flextend II, Fineline 2, Fineline Atrial J, Selute PicotipDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Krankenhaus der barmherzigen Schwestern

Ried im Innkreis, Austria

Outcomes

Primary Outcomes

QRS width

Ejection fraction

NYHA class

Data from ClinicalTrials.gov

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