Heart Failure
Conditions
Keywords
Heart Failure, Left Atrial Pressure Monitoring
Brief summary
This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication. The study will assess the safety, reliability, and preliminary efficacy of the HeartPOD™ system.
Detailed description
Direct cardiac measurements may provide an accurate, reliable and medically acceptable way of informing patients and physicians of worsening CHF prior to the development of symptoms. This may enable physicians to take preventative measures and avoid hospitalization. This is a feasibility study to assess the safety, reliability, and preliminary efficacy of the HeartPOD™ Heart Failure Management System with DynamicRx®. This feasibility study will be performed in two phases. The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the U.S.
Interventions
DEVICEHeartPOD™ System
HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks. | 6 Weeks | Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke. |
Countries
Australia, New Zealand, United States
Participant flow
Pre-assignment details
A total of 71 subjects were enrolled. The adverse events (both serious and non-serious) during the entire period of the study were evaluated in 71 subjects.
Participants by arm
| Arm | Count |
|---|---|
| HeartPOD™ System Implantation of HeartPOD™ System
HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day. | 71 |
| Total | 71 |
Baseline characteristics
| Characteristic | HeartPOD™ System |
|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 31 / 71 |
| other Total, other adverse events | 45 / 71 |
| serious Total, serious adverse events | 68 / 71 |
Outcome results
Primary
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.
Time frame: 6 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HeartPOD™ System | Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks. | 51 Participants |