Status:
COMPLETED
Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the Extension Phase of the COMPASS-HF study is to continue to observe the safety of the Chronicle® Implantable Hemodynamic Monitor (IHM) system and Chronicle ICD system and provide stud...
Detailed Description
For the purpose of the Extension Phase, the Chronicle IHM and ICD systems are for continued use in patients with moderate to severe heart failure and are intended to monitor hemodynamic information, i...
Eligibility Criteria
Inclusion
- Patient provides written informed consent for the Extension Phase
- Patient has an implanted Chronicle IHM or ICD device and is actively enrolled in one of the following studies: COMPASS-HF, Chronicle IHM Phase I/II, REDUCEhf or the PAH Pilot Study
Exclusion
- Patient unwilling to transmit their Chronicle IHM or ICD device data as directed by their study clinicians or unwilling to participate in protocol scheduled follow up visits (every six months)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00991120
Start Date
October 1 2009
End Date
April 1 2013
Last Update
November 30 2017
Active Locations (19)
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1
Birmingham, Alabama, United States
2
Springfield, Illinois, United States
3
Fort Wayne, Indiana, United States
4
Davenport, Iowa, United States