Clinical trial NCT01614652: A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
Official title: Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Congestive Heart Failure
Left Ventricular (LV) Systolic Dysfunction
Keywords: Congestive Heart Failure Due to LV Systolic Dysfunction
Lead sponsor: CardioKinetix, Inc
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of ischemic heart failure.


Eligibility criteria: 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

Primary outcomes:
measure: Death or re-hospitalization for Worsening Heart Failure (WHF)
timeFrame: At least 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Heart
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California (USC)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Clearwater
country: United States
facility: Morton Plant Hospital - Heart and Vascular Institute of Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Tampa
country: United States
facility: Florida Hospital Tampa - Pepin Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Heart Clinics
state: Idaho
city: Evanston
country: United States
facility: Evanston Hospital
state: Illinois
city: Naperville
country: United States
facility: Advocate Medical Group - Midwest Heart Foundation
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative - St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center of Indiana
state: Indiana
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: St Joseph Hospital/Kentucky One
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital/Louisville
state: Kentucky
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy-Michigan Heart
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's MAHI
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Hospital
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack UMC
state: New Jersey
city: Buffalo
country: United States
facility: Gates Vascular Institute/Buffalo General Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Cornell Campus
state: New York
city: Rochester
country: United States
facility: Univ. Of Rochester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Lindner Research Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute/Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Healthcare Network Cardiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Presbyterian Hospital
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Saint Thomas West Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute at St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Falls Church
country: United States
facility: Inova Heart and Vascular, Fairfax
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: Ohio State University
name: William T Abraham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals
name: Marco A Costa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Leslie Saxon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.