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

Sponsor

CardioKinetix, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00573560

Collaborator

(none)

Enrollment

Locations

Duration (Months)

2.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: VPD Implant System	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Feasibility Trial to Evaluate the VPD Implant System - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device. [6 months]

Secondary Outcome Measures

Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Hypersensitivity to contrast media
Allergy or contraindication to clopidogrel or aspirin
Evidence of ongoing infection (fever with temperature > 38°C and/or WBC > 15,000)
Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)
Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Hospital Center	Washington, D.C.	District of Columbia	United States	20010
2	Northwestern University Medical Center	Chicago	Illinois	United States	60611
3	Mission Hospitals	Asheville	North Carolina	United States	28802
4	The Ohio State University	Columbus	Ohio	United States	43210
5	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
6	Texas Heart Institute	Houston	Texas	United States	77030
7	Dedinje Cardiovascular Institute	Belgrade		Serbia	11040