None listed
Conditions
Brief summary
Despite improvements in treatment of heart failure over the last three decades it still carries a higher mortality rate than most cancers and is the most common reason for hospitalising people over the age of 65. Current treatment for heart failure is medication, adjusted based on the person's symptoms and / or weight gain. Adjustment of drug therapy can prevent rapid deterioration and the need for hospitalisation. Studies with cardiac catheterisation have demonstrated that one of the best predictors of the severity of heart failure and its response to treatment is raised left atrial pressure which often occurs several hours to several days before the onset of symptoms. Left atrial pressure cannot be accurately estimated from clinical assessment, and currently can only be estimated infrequently at single time points by invasive catheterisation of the right heart. This trial aims to test the safety and efficacy of a new pressure recording device (the HeartPOD). This device would be permanently implanted in the wall of the left atrium, to continuously monitor left atrial pressure. The pressure readings are viewed on a small ‘personal digital assistant (PDA)’ (hand held computer) which receives the information from the device by wireless transmission through the skin. Th trial will enrol 20 participants who will have the device implanted and monitored for 12 months. The first 6 weeks will be used to assess the safety of the device. For the first three months the participants medication will be altered based on symptoms, but pressure recordings will be taken to correlate pressures with symptoms. For months four to six medication will be adjusted based on symptoms and left atrial pressure. At months seven to twelve medication will be managed by the participant based on the pressure reading and instructions given by the PDA.
Interventions
This trial aims to test the safety and efficacy of a new pressure recording device (the HeartPOD). Once a subject has fulfilled the inclusion and exclusion criteria and signed a consent form, the device would be permanently implanted in the wall of the left atrium to continuously monitor left atrial pressure. The pressure readings are viewed on a hand held computer (PDA) which receives the information by wireless transmission through the skin.
The device is implanted and monitored for 12 months
This trial aims to test the safety and efficacy of a new pressure recording device (the HeartPOD). Once a subject has fulfilled the inclusion and exclusion criteria and signed a consent form, the device would be permanently implanted in the wall of the left atrium to continuously monitor left atrial pressure. The pressure readings are viewed on a hand held computer (PDA) which receives the information by wireless transmission through the skin. The device is implanted and monitored for 12 months. The first 6 weeks will be used to assess the safety of the device. For the first three months the participants medication will only be altered based on symptoms, but pressure recordings will be taken to correlate pressures with symptoms. For months four to six medication will be adjusted based on symptoms and left atrial pressure. At months seven to twelve medication will be managed by the participant based on the pressure reading and instructions given by the PDA.
Sponsors
St Jude Medical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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. American Heart Association(AHA)/American College of Cardiology(ACC) Stage C heart failure with New York Heart Association (NYHA) Class III or IV symptoms. Baseline 6-minute walk distance <450 meters (1476 feet) Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of Congestive Heart Failure (CHF). Female subjects of child-bearing 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. The subject or the subject’s legal representative has been informed of the nature of the study and agrees to it’s provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site
Exclusion criteria
Intractable Heart Failure (HF) with resting symptoms despite maximal medical therapy (AHA/ACC Stage D) or active listing for cardiac transplantation.( 6 months survival expected) Resting systolic blood pressure <90 or > 180 mm Hg. Acute Myocardial Infarction (MI), unstable ischemic syndrome within the last 6 weeks. Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within +/- six weeks. Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or >moderate or large small pericardial effusion. Surgical correction of congenital heart disease involving atrial septum Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA) within 6 months. History of uncorrected cerebral vascular disease Atrial thrombus or myxoma Chronic atrial fibrillation Symptomatic bradyarrhythmia or sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) unless successfully treated with cardiac rhythm management device for >6 weeks. Atrial septal thickness > 5 mm. 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 anti-platelet medications. Creatinine >2.5 gm/dl (220umol/L). Temperature >37.8 ?C 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 clinically interferes with the current study endpoints.
Outcome results
None listed