A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System

NCT01614652 | Terminated Phase 3 DMC

• 1 other identifier: VA0956
• Study Type: interventional
• Target: 331
• Locations: 2 countries
• Sites: 68

Brief Summary

Treatment of ischemic heart failure.

Conditions

Congestive Heart Failure; Left Ventricular (LV) Systolic Dysfunction

Keywords

Congestive Heart Failure Due to LV Systolic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Death or re-hospitalization for Worsening Heart Failure (WHF)

  At least 1 year

Study Arms (2)

Parachute Implant and All Appropriate Medical Therapy (AAMT)

EXPERIMENTAL

Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)

All Appropriate Medical Therapy (AAMT)

NO INTERVENTION

Interventions

CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT) DEVICE

CardioKinetix Parachute implant and all appropriate medical therapy

Parachute Implant and All Appropriate Medical Therapy (AAMT)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 79 years.
• Body Mass Index (BMI) ≤ 40.
• Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or "ambulatory" Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment.
• Patient is not hospitalized at the time of enrollment.
• Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment.
• The patient or the patient's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
• The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits.
• % ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE).
• Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE.
• Left ventricle must have appropriate anatomy (size and morphology) for implant placement using Cardiac Computed Tomography (CT) and confirmed by LV gram
• Candidates will be excluded from the study if ANY of the following conditions apply:

You may not qualify if:

• Untreated clinically significant coronary artery disease requiring revascularization.
• Cardiogenic shock within 72 hours of enrollment.
• Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.
• Excessive wall motion abnormalities outside the anteroapical region.
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• End stage renal disease requiring chronic dialysis.
• Obstructive Sleep Apnea (OSA): unless compliant on CPAP therapy or successful surgery.
• Hemoglobin \< 10 g/dl (female), \< 12 g/dl (male) or Creatinine \> 2.5mg/dl.
• Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Active peptic ulcer or GI bleeding within the past 3 months.
• A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre-medicated.
• Ongoing sepsis, including active endocarditis.
• Life expectancy \< 1 year due to associated non-cardiac co-morbid conditions or currently on the heart transplant lists.
• Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the patient from appropriate consent.
• Currently participating in an investigational drug or another device study (prior to primary endpoint reached).

Sponsors & Collaborators

• CardioKinetix, Inc: lead

Study Sites (68)

Arizona Heart

Phoenix, Arizona, 85013, United States

Location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Arkansas Heart

Little Rock, Arkansas, 72211, United States

Location

University of Southern California (USC)

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90069, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Morton Plant Hospital - Heart and Vascular Institute of Florida

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33444, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Florida Hospital Tampa - Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Kootenai Heart Clinics

Coeur d'Alene, Idaho, 83814, United States

Location

Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Advocate Medical Group - Midwest Heart Foundation

Naperville, Illinois, 60566, United States

Location

Prairie Education and Research Cooperative - St. John's Hospital

Springfield, Illinois, 62701, United States

Location

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46260, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242-1081, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

St Joseph Hospital/Kentucky One

Lexington, Kentucky, 40504, United States

Location

Jewish Hospital/Louisville

Louisville, Kentucky, 40202, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

St. Joseph Mercy-Michigan Heart

Ann Arbor, Michigan, 48197, United States

Location

MidMichigan Medical Center

Midland, Michigan, 48670, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

United Heart and Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

St. Luke's MAHI

Kansas City, Missouri, 64111, United States

Location

Nebraska Heart Hospital

Lincoln, Nebraska, 68526, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Hackensack UMC

Hackensack, New Jersey, 07601, United States

Location

Gates Vascular Institute/Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10065, United States

Location

Univ. Of Rochester Medical Center

Rochester, New York, 14643, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Ohio Health Research Institute/Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17062, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Einstein Healthcare Network Cardiology

Philadelphia, Pennsylvania, 19141, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center - Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Saint Thomas West Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78745, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Texas Heart Institute at St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

The Methodist Hospital

Houston, Texas, 77056, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Inova Heart and Vascular, Fairfax

Falls Church, Virginia, 22042, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

Related Publications (1)

• Costa MA, Pencina M, Nikolic S, Engels T, Templin B, Abraham WT. The PARACHUTE IV trial design and rationale: percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure and dilated left ventricles. Am Heart J. 2013 Apr;165(4):531-6. doi: 10.1016/j.ahj.2012.12.022. Epub 2013 Feb 19.

  PMID: 23537969 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• William T Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Marco A Costa, MD, PhD

  University Hospitals

  PRINCIPAL INVESTIGATOR

• Leslie Saxon, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 8, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

US (67); CA (1)