Back to resultsAustria Study - Analysis of Difference Between Active and Passive Fixation Leads
Primary Purpose
Bradycardia, Heart Block, Sick Sinus Syndrome
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
Sponsored by
About this trial
This is an interventional treatment trial for Bradycardia
Eligibility Criteria
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
Sites / Locations
- Krankenhaus der barmherzigen Schwestern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active fixation lead
Passive fixation lead
Arm Description
Active fixation lead was implanted
Passive fixation lead was implanted
Outcomes
Primary Outcome Measures
QRS width
Ejection fraction
NYHA class
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00180557
Brief Title
Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
Official Title
Analyse Der Unterschiede Zwischen Aktiv-fixierenden Und Passiv-fixierenden Stimulations-Elektroden Hinsichtlich Implantationsdauer Und Elektrischer Parameter
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Guidant Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Heart Block, Sick Sinus Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active fixation lead
Arm Type
Experimental
Arm Description
Active fixation lead was implanted
Arm Title
Passive fixation lead
Arm Type
Active Comparator
Arm Description
Passive fixation lead was implanted
Intervention Type
Device
Intervention Name(s)
Flextend II, Fineline 2, Fineline Atrial J, Selute Picotip
Primary Outcome Measure Information:
Title
QRS width
Title
Ejection fraction
Title
NYHA class
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Nimeth, MD
Organizational Affiliation
Krankenhaus der barmherzigen Schwestern Ried im Innkreis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus der barmherzigen Schwestern
City
Ried im Innkreis
Country
Austria
12. IPD Sharing Statement
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Austria Study - Analysis of Difference Between Active and Passive Fixation Leads
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