Status:
COMPLETED
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
Lead Sponsor:
Biotronik, Inc.
Conditions:
Patient Indicated for an ICD
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the nu...
Eligibility Criteria
Inclusion
- Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.
- Able to utilize the HM system throughout the study
- Ability to give informed consent
- Geographically stable and able to return for regular follow-ups for fifteen (15) months
- At least 18 years old
Exclusion
- Patients who do not fulfill all inclusion criteria
- Pacemaker dependent
- Currently enrolled in any other cardiac clinical investigation
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
1450 Patients enrolled
Trial Details
Trial ID
NCT00336284
Start Date
November 1 2005
End Date
June 1 2009
Last Update
August 3 2010
Active Locations (110)
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1
Site 55
Birmingham, Alabama, United States, 35294
2
Site 68
Mesa, Arizona, United States, 85205
3
Site 99
Phoenix, Arizona, United States, 85016
4
Site 118
Bakersfield, California, United States, 93301