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

Sponsor
CardioKinetix, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT01614652
Collaborator
(none)
331
Enrollment
68
Locations
2
Arms
54
Duration (Months)
4.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Treatment of ischemic heart failure.

Condition or Disease Intervention/Treatment Phase
  • Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
331 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT)

Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
No Intervention: All Appropriate Medical Therapy (AAMT)

Outcome Measures

Primary Outcome Measures

  1. Death or re-hospitalization for Worsening Heart Failure (WHF) [At least 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arizona Heart Phoenix Arizona United States 85013
2 University of Arizona Medical Center Tucson Arizona United States 85724
3 Arkansas Heart Little Rock Arkansas United States 72211
4 University of Southern California (USC) Los Angeles California United States 90033
5 Cedars-Sinai Medical Center Los Angeles California United States 90069
6 UC Davis Medical Center Sacramento California United States 95817
7 Morton Plant Hospital - Heart and Vascular Institute of Florida Clearwater Florida United States 33756
8 Delray Medical Center Delray Beach Florida United States 33444
9 Tallahassee Research Institute Tallahassee Florida United States 32308
10 Florida Hospital Tampa - Pepin Heart Institute Tampa Florida United States 33613
11 Piedmont Atlanta Hospital Atlanta Georgia United States 30309
12 Kootenai Heart Clinics Coeur d'Alene Idaho United States 83814
13 Evanston Hospital Evanston Illinois United States 60201
14 Advocate Medical Group - Midwest Heart Foundation Naperville Illinois United States 60566
15 Prairie Education and Research Cooperative - St. John's Hospital Springfield Illinois United States 62701
16 St. Vincent Heart Center of Indiana Indianapolis Indiana United States 46260
17 Iowa Heart Center Des Moines Iowa United States 50266
18 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242-1081
19 University of Kansas Hospital Kansas City Kansas United States 66160
20 Baptist Health Lexington Lexington Kentucky United States 40503
21 St Joseph Hospital/Kentucky One Lexington Kentucky United States 40504
22 Jewish Hospital/Louisville Louisville Kentucky United States 40202
23 Cardiovascular Institute of the South Houma Louisiana United States 70360
24 LSU Health Sciences Center New Orleans Louisiana United States 70112
25 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
26 University of Maryland Medical Center Baltimore Maryland United States 21201
27 Tufts Medical Center Boston Massachusetts United States 02111
28 St. Joseph Mercy-Michigan Heart Ann Arbor Michigan United States 48197
29 MidMichigan Medical Center Midland Michigan United States 48670
30 University of Minnesota Medical Center Minneapolis Minnesota United States 55455
31 United Heart and Vascular Clinic Saint Paul Minnesota United States 55102
32 St. Luke's MAHI Kansas City Missouri United States 64111
33 Nebraska Heart Hospital Lincoln Nebraska United States 68526
34 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
35 Hackensack UMC Hackensack New Jersey United States 07601
36 Gates Vascular Institute/Buffalo General Hospital Buffalo New York United States 14203
37 Mount Sinai Medical Center New York New York United States 10029
38 New York Presbyterian Hospital - Cornell Campus New York New York United States 10065
39 Univ. Of Rochester Medical Center Rochester New York United States 14643
40 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
41 The Christ Hospital Lindner Research Center Cincinnati Ohio United States 45219
42 University Hospitals Cleveland Ohio United States 44106
43 The Ohio State University Columbus Ohio United States 43210
44 Ohio Health Research Institute/Riverside Methodist Hospital Columbus Ohio United States 43214
45 Integris Baptist Medical Center Oklahoma City Oklahoma United States 73112
46 Oklahoma Heart Hospital Oklahoma City Oklahoma United States 73120
47 Lancaster General Hospital Lancaster Pennsylvania United States 17062
48 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
49 Einstein Healthcare Network Cardiology Philadelphia Pennsylvania United States 19141
50 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
51 University of Pittsburgh Medical Center - Presbyterian Hospital Pittsburgh Pennsylvania United States 15213
52 Pinnacle Health Cardiovascular Institute Wormleysburg Pennsylvania United States 17043
53 The Miriam Hospital Providence Rhode Island United States 02906
54 Wellmont Holston Valley Medical Center Kingsport Tennessee United States 37660
55 Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee United States 37934
56 Saint Thomas West Hospital Nashville Tennessee United States 37205
57 Vanderbilt University Nashville Tennessee United States 37232
58 Texas Cardiac Arrhythmia Research Foundation Austin Texas United States 78745
59 Memorial Hermann Hospital Houston Texas United States 77030
60 Texas Heart Institute at St. Luke's Episcopal Hospital Houston Texas United States 77030
61 The Methodist Hospital Houston Texas United States 77056
62 University of Utah Salt Lake City Utah United States 84132
63 Inova Heart and Vascular, Fairfax Falls Church Virginia United States 22042
64 Sentara Cardiovascular Research Institute Norfolk Virginia United States 23507
65 Virginia Commonwealth University Medical Center Richmond Virginia United States 23298
66 Swedish Medical Center Seattle Washington United States 98122
67 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
68 St. Paul's Hospital Vancouver British Columbia Canada V6E 1M7

Sponsors and Collaborators

  • CardioKinetix, Inc

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT01614652
Other Study ID Numbers:
  • VA0956
First Posted:
Jun 8, 2012
Last Update Posted:
Jun 23, 2017
Last Verified:
Jun 1, 2017
Keywords provided by CardioKinetix, Inc
Congestive Heart Failure Due to LV Systolic Dysfunction
Additional relevant MeSH terms:
Heart Failure
Systolic Murmurs

Study Results

No Results Posted as of Jun 23, 2017