Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
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ClinicalTrials.gov Identifier: NCT00180557 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Last Update Posted
: March 17, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bradycardia Heart Block Sick Sinus Syndrome | Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter |
Study Start Date : | September 2003 |
Actual Study Completion Date : | May 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: Active fixation lead
Active fixation lead was implanted
|
Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip |
Active Comparator: Passive fixation lead
Passive fixation lead was implanted
|
Device: Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip |
- QRS width
- Ejection fraction
- NYHA class

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180557
Austria | |
Krankenhaus der barmherzigen Schwestern | |
Ried im Innkreis, Austria |
Principal Investigator: | C Nimeth, MD | Krankenhaus der barmherzigen Schwestern Ried im Innkreis |
Responsible Party: | Rainer Habeler, Guidant Austria |
ClinicalTrials.gov Identifier: | NCT00180557 History of Changes |
Other Study ID Numbers: |
Austria Study v. 1.2 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | March 17, 2015 |
Last Verified: | December 2007 |
Additional relevant MeSH terms:
Bradycardia Sick Sinus Syndrome Heart Block Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Arrhythmia, Sinus |