A trial investigating the safety and effectiveness of the HeartPOD as a hemodynamically guided home self-therapy in severe heart failure patients

St Jude Medical0 sites20 target enrollmentOctober 17, 2007

Overview

No summary available.

Registry

who.int

Start Date

October 17, 2007

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.