Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
- Conditions
- Sick Sinus SyndromeBradycardiaHeart Block
- Interventions
- Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Age < 18 years, indication for pacemaker implantation according to current guidelines, written consent of the patient
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
- Arm && Interventions
Group Intervention Description Active fixation lead Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip Active fixation lead was implanted Passive fixation lead Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip Passive fixation lead was implanted
- Primary Outcome Measures
Name Time Method QRS width Ejection fraction NYHA class
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Krankenhaus der barmherzigen Schwestern
🇦🇹Ried im Innkreis, Austria