Bradycardia Clinical Trial
Official title:
Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter
Verified date | December 2007 |
Source | Guidant Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Austria: Federal Ministry for Health and Women |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Krankenhaus der barmherzigen Schwestern | Ried im Innkreis |
Lead Sponsor | Collaborator |
---|---|
Guidant Corporation |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QRS width | |||
Primary | Ejection fraction | |||
Primary | NYHA class |
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