PIII PV Loop: PARACHUTE III Pressure Volume Loop Sub-Study

Sponsor

CardioKinetix, Inc (Industry)

Overall Status

Terminated

CT.gov ID

NCT02241837

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to assess the longterm safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease. This sub-study has the additional assessment of improvement in Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure and volume as functional parameters of the Left Ventricle.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Myocardial Infarction

Detailed Description

While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the longterm safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jun 1, 2017

Outcome Measures

Primary Outcome Measures

Assessment of long term safety of the Parachute system from baseline to 1 year and annually [5 years]
Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.

Secondary Outcome Measures

Change in Left Ventricular Volume Indices between baseline, 6 months, and annually [6 months and annually to 5 years]
Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Candidates for this study must meet ALL of the following inclusion criteria:

Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
Subject is not hospitalized at time of enrollment.
NYHA Class at time of enrollment, either:

NYHA Class III or Ambulatory 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

LVEF >15 or% and ≤ 40% as measured by echocardiography.
Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
Eligible for cardiac surgery
Between 18 and 79 years of age (inclusive)
Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
Provide written informed consent
Agree to the protocol-required follow-up

Exclusion Criteria:

Candidates will be excluded from the study if ANY of the following conditions apply:

Untreated clinically significant coronary artery disease requiring intervention.
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 pacemaker, ICD, or CRT device 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
A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.
Aortic valve replacement or repair
Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
Active peptic ulcer or GI bleeding within the past 3 months
Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
History of Kawasaki's disease
Patient on dialysis or expected to require hemodialysis within 12 months
Patient has chronic liver disease
Impaired renal function that places patient at risk of contrast induced renal failure
Ongoing sepsis, including active endocarditis.
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.)