Clincosm LogoSign in Get a demo

Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT00991120
Collaborator
(none)
165
Enrollment
19
Locations
42
Duration (Months)
8.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)

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

Study Type:
Observational
Actual Enrollment :
165 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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 Criteria:
    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 Springfield Illinois United States
    3 Fort Wayne Indiana United States
    4 Davenport Iowa United States
    5 Boston Massachusetts United States
    6 Rochester Minnesota United States
    7 Kansas City Missouri United States
    8 Lincoln Nebraska United States
    9 New Brunswick New Jersey United States
    10 Cincinnati Ohio United States
    11 Columbus Ohio United States
    12 Oklahoma City Oklahoma United States
    13 Lancaster Pennsylvania United States
    14 Philadelphia Pennsylvania United States
    15 Charleston South Carolina United States
    16 Nashville Tennessee United States
    17 Houston Texas United States
    18 Salt Lake City Utah United States
    19 Norfolk Virginia United States

    Sponsors and Collaborators

    • Medtronic Cardiac Rhythm and Heart Failure

    Investigators

    • Study Chair: COMPASS-HF Extension Team, Medtronic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Cardiac Rhythm and Heart Failure
    ClinicalTrials.gov Identifier:
    NCT00991120
    Other Study ID Numbers:
    • COMPASS-HF Extension
    First Posted:
    Oct 7, 2009
    Last Update Posted:
    Nov 30, 2017
    Last Verified:
    Nov 1, 2017
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Nov 30, 2017