Heart FailureNCT00991120
Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 19 sitesUnited States
- Study dates
- Oct 2009to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Charleston, South Carolina
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Davenport, Iowa
Study site
Fort Wayne, Indiana
Study site
Houston, Texas
Study site
Kansas City, Missouri
Study site
Lancaster, Pennsylvania
Study site
Lincoln, Nebraska
Study site
Nashville, Tennessee
Study site
New Brunswick, New Jersey
Study site
Norfolk, Virginia
Study site
Oklahoma City, Oklahoma
Study site
Philadelphia, Pennsylvania
Study site
Rochester, Minnesota
Study site
Salt Lake City, Utah
Study site
Springfield, Illinois
About this study
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.
Read the 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, including right ventricular and pulmonary artery pressures, heart rate and activity. The COMPASS-HF Extension Phase includes the following Chronicle IHM studies:
- The Chronicle IHM Phase I/II study, which was a 148 patient technology assessment study that began enrolling patients in 1998 and completed the endpoint driven follow up period of 3 months for safety and 12 months for efficacy in 2002
- The Chronicle Offers Management to Patients with Advanced Signs \& Symptoms of Heart Failure (COMPASS-HF) study, which was a 274 patient randomized study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 6 months in 2005
- The Pulmonary Arterial Hypertension Pilot (PAH Pilot) study, which was a 24 patient pilot study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 12 weeks in 2006
- The Reducing Decompensation Events Utilizing intraCardiac Pressures in Patients with Chronic HF (REDUCEhf) study, which was a 400 patient randomized study that began enrolling patients in 2006 and completed endpoint driven follow up period of 12 months in 2010.
In all four studies, patients were implanted with a Chronicle IHM or ICD system and upon completion of the endpoint driven follow up period, entered long term follow up and have continued to be seen every six months for study visits.
As the Chronicle IHM or ICD system has not received U.S. Food and Drug Administration approval, the COMPASS-HF Extension Phase is being initiated as a means to allow continued access of Chronicle IHM data to study investigators in one concurrently enrolled study and follow up schedule. No additional study objectives or new enrollments will be captured in the COMPASS-HF Extension Phase.
- Conditions
- Heart Failure
- Being tested
- Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)Device
Also called Chronicle IHM, Chronicle ICD
Surgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac lead
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- COMPASS-HF Extension Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991120
- Sponsor's protocol ID
- COMPASS-HF Extension
- Status last verified
- Nov 2017
- First submitted
- 6 Oct 2009
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study
- ClinicalTrials.gov ID
- NCT00991120
- Acronym / sponsor ID
- COMPASS-HF Extension
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, including right ventricular and pulmonary artery pressures, heart rate and activity. The COMPASS-HF Extension Phase includes the following Chronicle IHM studies:
- The Chronicle IHM Phase I/II study, which was a 148 patient technology assessment study that began enrolling patients in 1998 and completed the endpoint driven follow up period of 3 months for safety and 12 months for efficacy in 2002
- The Chronicle Offers Management to Patients with Advanced Signs \& Symptoms of Heart Failure (COMPASS-HF) study, which was a 274 patient randomized study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 6 months in 2005
- The Pulmonary Arterial Hypertension Pilot (PAH Pilot) study, which was a 24 patient pilot study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 12 weeks in 2006
- The Reducing Decompensation Events Utilizing intraCardiac Pressures in Patients with Chronic HF (REDUCEhf) study, which was a 400 patient randomized study that began enrolling patients in 2006 and completed endpoint driven follow up period of 12 months in 2010.
In all four studies, patients were implanted with a Chronicle IHM or ICD system and upon completion of the endpoint driven follow up period, entered long term follow up and have continued to be seen every six months for study visits.
As the Chronicle IHM or ICD system has not received U.S. Food and Drug Administration approval, the COMPASS-HF Extension Phase is being initiated as a means to allow continued access of Chronicle IHM data to study investigators in one concurrently enrolled study and follow up schedule. No additional study objectives or new enrollments will be captured in the COMPASS-HF Extension Phase.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)Also: Chronicle IHM, Chronicle ICDSurgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac lead | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COMPASS-HF Extension Team study chair
Medtronic
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.