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

Congestive Heart Failure Clinical Trial

— PARACHUTE IV  

Official title:

Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01614652
• Other study ID #: VA0956
• Status: Terminated
• Phase: Phase 3
• First received: June 4, 2012
• Last updated: June 21, 2017
• Start date: December 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: CardioKinetix, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Treatment of ischemic heart failure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 331
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Clinical Inclusion Criteria:

• 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.

Inclusion Criteria based on Imaging:

• 15% = 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:

Clinical Exclusion Criteria:

• 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).

• Female patients with childbearing potential and a positive urine pregnancy test .

Anatomical Exclusion Criteria:

• Pre-existing prosthetic heart valve in mitral or aortic position.

• Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+.

• Presence of anatomic anomalies (including severe calcification) detected by cardiac imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded deployment and/or operation of the Parachute Implant

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure
• Left Ventricular (LV) Systolic Dysfunction

Intervention

Device:
• CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia
United States	St. Joseph Mercy-Michigan Heart	Ann Arbor	Michigan
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Gates Vascular Institute/Buffalo General Hospital	Buffalo	New York
United States	The Christ Hospital Lindner Research Center	Cincinnati	Ohio
United States	Morton Plant Hospital - Heart and Vascular Institute of Florida	Clearwater	Florida
United States	University Hospitals	Cleveland	Ohio
United States	Kootenai Heart Clinics	Coeur d'Alene	Idaho
United States	Ohio Health Research Institute/Riverside Methodist Hospital	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Delray Medical Center	Delray Beach	Florida
United States	Iowa Heart Center	Des Moines	Iowa
United States	Evanston Hospital	Evanston	Illinois
United States	Inova Heart and Vascular, Fairfax	Falls Church	Virginia
United States	Hackensack UMC	Hackensack	New Jersey
United States	Cardiovascular Institute of the South	Houma	Louisiana
United States	Memorial Hermann Hospital	Houston	Texas
United States	Texas Heart Institute at St. Luke's Episcopal Hospital	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	St. Luke's MAHI	Kansas City	Missouri
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Baptist Health Lexington	Lexington	Kentucky
United States	St Joseph Hospital/Kentucky One	Lexington	Kentucky
United States	Nebraska Heart Hospital	Lincoln	Nebraska
United States	Arkansas Heart	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Southern California (USC)	Los Angeles	California
United States	Jewish Hospital/Louisville	Louisville	Kentucky
United States	MidMichigan Medical Center	Midland	Michigan
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Advocate Medical Group - Midwest Heart Foundation	Naperville	Illinois
United States	Saint Thomas West Hospital	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	LSU Health Sciences Center	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Integris Baptist Medical Center	Oklahoma City	Oklahoma
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Einstein Healthcare Network Cardiology	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Heart	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center - Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	The Miriam Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	Univ. Of Rochester Medical Center	Rochester	New York
United States	UC Davis Medical Center	Sacramento	California
United States	United Heart and Vascular Clinic	Saint Paul	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Swedish Medical Center	Seattle	Washington
United States	Prairie Education and Research Cooperative - St. John's Hospital	Springfield	Illinois
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Florida Hospital Tampa - Pepin Heart Institute	Tampa	Florida
United States	University of Arizona Medical Center	Tucson	Arizona
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CardioKinetix, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or re-hospitalization for Worsening Heart Failure (WHF)		At least 1 year