Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00547729
First received: October 19, 2007
Last updated: August 24, 2012
Last verified: August 2012

October 19, 2007
August 24, 2012
March 2005
June 2008   (final data collection date for primary outcome measure)
Freedom from Major Adverse Cardiac and Neurological Events (MACNE) at 6 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Freedom from Major Adverse Cardiac and Neurological Events (MACNE) at 6 weeks. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00547729 on ClinicalTrials.gov Archive Site
Not Provided
  • Device Success defined as satisfactory deployment and performance of the study device and the absence of device extraction for infection or other cause. [ Time Frame: 12 months ]
  • Validation of Valsalva calibration procedure with Swan Ganz catheter pulmonary capillary wedge pressure measurement at implant procedure and 3 and 12 months. [ Time Frame: 12 months ]
  • Stability and accuracy of calibration of LAP, as assessed by Valsalva maneuver calibration procedure at implant procedure, 2, and 6 weeks and 3, 6, 9, and 12 months. [ Time Frame: 12 months ]
  • LAP validation (concordance of the HeartPOD™ System LAP measurement with Swan-Ganz catheter pulmonary capillary wedge pressure [PCWP] measurement at implant, and 3 and 12 months). Concordance defined as LAP averaging within ± 5 mmHg of PCWP. [ Time Frame: 12 months ]
  • Temperature accuracy defined as difference error ≤ ± 0.5º C of blood temperature. [ Time Frame: 12 months ]
  • IEGM (intracardiac electrogram) stability defined by observable P and R wave for patients in sinus rhythm: at implant vs. 3 and 12 months. [ Time Frame: 12 months ]
Not Provided
Not Provided
 
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Heart Failure
Device: Left Atrial Pressure monitoring
HeartPOD™ device automatically measures heart pressures throughout the day. This data is collected at follow up visits.
Other Name: HeartPOD™ System
Experimental: 1
Implantation of HeartPOD™ System
Intervention: Device: Left Atrial Pressure monitoring

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 and < 85.
  • Documented history of congestive heart failure resulting from ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction of at least 6 months duration.
  • Patients with LVEF < 40% should receive maximally tolerated doses of ACE-I (or ARB if ACE-I is not tolerated), beta blockers, and anti-aldosterone therapy. The combination of hydralazine and nitrates should be considered in the persistently symptomatic African American patient.
  • A history of NYHA Class II (OUS only), III or IV symptoms.
  • Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of CHF or one (1) presentation to the Emergency Department or Clinic requiring parenteral diuretic, vasodilator, inotrope, nesiritide, or equivalent treatment.
  • Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
  • Central venous vascular access.
  • Capable of Valsalva maneuver with airway pressure > 40 mm Hg for 10 seconds.
  • The subject and the treating physician agree that the subject will comply with all required post-procedure follow-up, and that the patient is capable of correct device use as outlined in the protocol.
  • Written informed consent.

Exclusion Criteria:

  • Intractable HF with resting symptoms despite maximal medical therapy or active listing for cardiac transplantation (< 6 months survival expected).
  • Resting systolic blood pressure < 90 or > 180 mmHg.
  • Acute MI, unstable ischemic syndrome within the last 6 weeks.
  • Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within 6 weeks.
  • Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or moderate or large pericardial effusion.
  • Subject has a history of deep venous thrombosis or pulmonary embolism.
  • Surgical correction of congenital heart disease involving atrial septum.
  • CVA or TIA within 6 months. History of uncorrected cerebral vascular disease.
  • Atrial or ventricular thrombus, tumor or systemic thromboembolism.
  • Chronic atrial fibrillation.
  • Symptomatic bradyarrhythmia or sustained VT/VF unless successfully treated with cardiac rhythm management device for 6 weeks.
  • Atrial septal defect or patent foramen ovale > 2 mm in diameter.
  • Life expectancy < 1 year from malignancy, primary pulmonary hypertension, renal, hepatic, or neurological condition, etc.
  • Gastrointestinal bleeding during the last 6 months.
  • Coagulopathy or uninterruptible anticoagulation therapy or unable to take antiplatelet medications.
  • Creatinine > 2.5 gm/dl
  • Temperature > 37.8C or white blood cell count (WBC) > 13,000/mm3.
  • The subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   New Zealand
 
NCT00547729
HP-05-04/HP-12-04
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Study Chair: William T. Abraham, MD, FACC Ohio State University
Principal Investigator: Henry Krum, MD Monash University/Alfred Hosptial
St. Jude Medical
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP