Status:
COMPLETED
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
Lead Sponsor:
Biotronik, Inc.
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop...
Detailed Description
All patients enrolled in the CLEAR study are implanted with a Cylos pacemaker with Closed Loop Stimulation (CLS) rate adaption technology. Any legally marketed pacing leads may be implanted with the C...
Eligibility Criteria
Inclusion
- Implanted within the last 45 days or being considered for implant with a BIOTRONIK pacemaker utilizing CLS rate adaptation technology (currently the Cylos family of pacemakers).
- Ability to give written informed consent
- Geographically stable and able to return for regular follow-ups for 12 months after ADL testing
- At least 18 years old
Exclusion
- Patients physically limited and unable to perform all or parts of the ADL testing
- Currently enrolled in any other clinical study
- Patients with medical reasons that preclude regular participation in the follow-ups
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
1491 Patients enrolled
Trial Details
Trial ID
NCT00355797
Start Date
May 1 2006
End Date
December 1 2010
Last Update
December 20 2012
Active Locations (99)
Enter a location and click search to find clinical trials sorted by distance.
1
Raymond Fernandez
Albertville, Alabama, United States, 35951
2
Cardiology Associates-Gadsden
Gadsden, Alabama, United States, 35901
3
North Alabama Cardiology Center
Gadsden, Alabama, United States, 35901
4
Richard Kim, MD
Jasper, Alabama, United States, 35501