A trial investigating the HeartPOD, a new heart pressure monitoring device, to optimise treatment in patients with severe heart failure
- Conditions
- Heart FailureCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12607000531415
- Lead Sponsor
- St Jude Medical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The HeartPOD is safe and reliably measures left atrial pressure in patients with severe heart failure.[6 weeks]
- Secondary Outcome Measures
Name Time Method The Heart POD is effective in guiding titration of heart failure treatment[12 months]