Bradycardia, Heart Block, Sick Sinus Syndrome
Conditions
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.
Interventions
DEVICEFlextend II, Fineline 2, Fineline Atrial J, Selute Picotip
Sponsors
Guidant Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NYHA class | — |
| QRS width | — |
| Ejection fraction | — |
Countries
Austria
Outcome results
None listed