Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients

Completed · Phase 1

Conditions studied: Heart Failure

In brief

The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.

Key facts

Study ID

NCT00573560

Run by

CardioKinetix, Inc

People needed

20

Starts

2007-12-01

Expected to finish

2014-06-01

Last updated by the study team

2017-06-22

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
• Diagnosis of heart failure for a minimum of 6 months prior to enrollment
• NYHA Class at time of enrollment, either:
• NYHA Class III or IV - if predominant during the 3-month period prior to enrollment
• NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment and ≥ 1 hospitalization for heart failure during 12-month period prior to enrollment
• LVEF ≤ 40% as measured by echocardiography
• Left ventricle must have appropriate anatomy as measured by Cardiac CT per the VPD Implant sizing criteria described in the device's Instructions For Use
• Eligible for cardiac surgery
• Between 18 and 74 years of age (inclusive)
• Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
• Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
• Provide written informed consent
• Agree to the protocol-required follow-up

You may not qualify if…

• Myocardial ischemia requiring PCI or CABG
• Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
• Cardiogenic shock within 72 hours of enrollment
• Revascularization procedure (PCI or CABG) within 60 days of enrollment
• Patient has received a CRT device within 60 days of enrollment
• Patient diagnosed with significant valve disease (AI >1+; MR >2+) which may or may not require surgery
• Patient has received an ICD within 60 days of enrollment
• Patient has received a pacemaker within 60 days of enrollment
• History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
• Patients with a history or a current diagnosis of either persistent or paroxysmal atrial fibrillation as well as patients who present with a contraindication to oral anticoagulant therapy
• Aortic valve replacement or repair
• Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg
• Resting heart rate more than 120 bpm
• Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium
• History of bleeding diathesis or a major coagulopathy (i.e. platelet count < 100,000 plts/ml whole blood; PTT or PT > 1.3 times control value)
• GI bleed requiring transfusion within the past 3 months
• Patient has suffered a stroke within the past 6 months
• Evidence of severe calcification in the VPD Implant attachment zone
• Evidence of a significant sub-aortic obstruction ("left moderator band") in the area of implant
• History of Kawasaki's disease
• Patient has received a heart, lung, liver and/or kidney transplant
• Patient on dialysis or expected to require hemodialysis within 12 months
• Patient has chronic liver disease
• Patient has received intracardiac gene therapy or stem cell therapy
• Creatinine > 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Northwestern University Medical Center — Chicago, Illinois, United States
• Mission Hospitals — Asheville, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Texas Heart Institute — Houston, Texas, United States
• Dedinje Cardiovascular Institute — Belgrade, Serbia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.