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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by CardioKinetix, Inc
Sponsor:
Information provided by (Responsible Party):
CardioKinetix, Inc
ClinicalTrials.gov Identifier:
NCT01614652
First received: June 4, 2012
Last updated: September 4, 2014
Last verified: September 2014

June 4, 2012
September 4, 2014
December 2012
June 2016   (final data collection date for primary outcome measure)
Death or re-hospitalization for Worsening Heart Failure (WHF) [ Time Frame: At least 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01614652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System
Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Treatment of ischemic heart failure.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congestive Heart Failure
  • Left Ventricular (LV) Systolic Dysfunction
Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
CardioKinetix Parachute implant and all appropriate medical therapy
  • Experimental: Parachute Implant and All Appropriate Medical Therapy (AAMT)
    Intervention: Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
  • No Intervention: All Appropriate Medical Therapy (AAMT)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
560
June 2020
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact: Richelle Massey, MBA 650-364-7016 ext 434 rmassey@cardiokinetix.com
United States
 
NCT01614652
VA0956
Yes
CardioKinetix, Inc
CardioKinetix, Inc
Not Provided
Principal Investigator: William T Abraham, MD Ohio State University
Principal Investigator: Marco A Costa, MD, PhD University Hospitals
CardioKinetix, Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP