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

Guidant

Status and phase: Completed; Phase 4

Conditions: Bradycardia; Heart Block; Sick Sinus Syndrome

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00180557

Austria Study v. 1.2

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Active fixation lead

Experimental group

Description:

Active fixation lead was implanted

Treatment:

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

Passive fixation lead

Active Comparator group

Description:

Passive fixation lead was implanted

Treatment:

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