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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00547729 |
Most people with heart failure take a number of medications that work in different ways. Patients and their families need to keep track of prescribed medications and follow instructions on how much to take and when to take them. Currently, doctors are guided primarily by symptoms. The device being studied in this trial (called the HeartPOD™ System) monitors heart function from inside your body and alerts the patient and physician of necessary changes to your medication.
Condition | Intervention | Phase |
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Heart Failure |
Device: Left Atrial Pressure monitoring |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-Center, Non-Randomized, Open Label Study. |
Enrollment: | 40 |
Study Start Date: | March 2005 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Implantation of HeartPOD™ System
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Device: Left Atrial Pressure monitoring
HeartPOD™ device automatically measures heart pressures throughout the day. This data is collected at follow up visits.
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The Sponsor believes that direct measurements from your heart may provide an accurate, reliable and medically acceptable way of telling you and your doctor that your CHF is worsening hours to days before the above symptoms would develop and you would notice. This may enable you and your doctor to take preventative measures and avoid hospitalization.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
Scripps Green Hospital | |
La Jolla, California, United States, 92037 | |
United States, Ohio | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Oklahoma | |
Oklahoma Heart Hospital | |
Oklahoma City, Oklahoma, United States, 73120 | |
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
New Zealand | |
Christchurch Hospital | |
Christchurch, New Zealand | |
University of Auckland | |
Auckland, New Zealand |
Study Chair: | William T. Abraham, MD, FACC | Ohio State University |
Principal Investigator: | Henry Krum, MD | Monash University/Alfred Hosptial |
Responsible Party: | St. Jude Medical, CRMD ( Director, Clinical Affairs ) |
Study ID Numbers: | HP-05-04/HP-12-04 |
Study First Received: | October 19, 2007 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00547729 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Human Research Ethics Committee |
Heart Failure Left Atrial Pressure Monitoring |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |