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

June 21, 2017 updated by: CardioKinetix, Inc

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

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.

Study Overview

Status

Completed

Conditions

Heart Failure

Intervention / Treatment

Device: VPD Implant System

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Serbia
- - Belgrade, Serbia, 11040
    - Dedinje Cardiovascular Institute
United States
- District of Columbia
  - Washington, D.C., District of Columbia, United States, 20010
    - Washington Hospital Center
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University Medical Center
- North Carolina
  - Asheville, North Carolina, United States, 28802
    - Mission Hospitals
- Ohio
  - Columbus, Ohio, United States, 43210
    - The Ohio State University
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
- Texas
  - Houston, Texas, United States, 77030
    - Texas Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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. Time Frame: 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Time Frame: 12 months	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioKinetix, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria