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

Phase 4

Completed

• Conditions: Sick Sinus Syndrome; Bradycardia; Heart Block

• Registration Number: NCT00180557
• Lead Sponsor: Guidant Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-16
• Study Completion: 2007-05
• Status Verified: 2007-12
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
QRS width
Ejection fraction
NYHA class

Trial Locations

Locations (1)

Krankenhaus der barmherzigen Schwestern; 🇦🇹 Ried im Innkreis, Austria