Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study
1 other identifier
observational
165
1 country
19
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 study doctors continued access to the heart pressure information recorded by the Chronicle devices which may be used to help manage heart failure. The Extension Phase of the COMPASS-HF study is limited to people who have already received the investigational system and are currently enrolled in a Chronicle IHM or ICD study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2009
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 30, 2017
November 1, 2017
3.5 years
October 6, 2009
November 28, 2017
Conditions
Interventions
Surgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac lead
Eligibility Criteria
The study population will consist of all currently enrolled patients in the COMPASS-HF, Chronicle IHM Phase I/II, REDUCEhf and PAH Pilot studies who provide written informed consent for the Extension Phase.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Springfield, Illinois, United States
Unknown Facility
Fort Wayne, Indiana, United States
Unknown Facility
Davenport, Iowa, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Lincoln, Nebraska, United States
Unknown Facility
New Brunswick, New Jersey, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Lancaster, Pennsylvania, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Charleston, South Carolina, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
COMPASS-HF Extension Team
Medtronic
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 7, 2009
Study Start
October 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 30, 2017
Record last verified: 2017-11