Trial record 1 of 1 for:    PARACHUTE IV
Previous Study | Return to List | Next Study

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
  Purpose

Treatment of ischemic heart failure.


Condition Intervention Phase
Congestive Heart Failure
Left Ventricular (LV) Systolic Dysfunction
Device: CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by CardioKinetix, Inc:

Primary Outcome Measures:
  • Death or re-hospitalization for Worsening Heart Failure (WHF) [ Time Frame: At least 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 560
Study Start Date: December 2012
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614652

Contacts
Contact: Richelle Massey, MBA 650-364-7016 ext 434 rmassey@cardiokinetix.com

  Show 55 Study Locations
Sponsors and Collaborators
CardioKinetix, Inc
Investigators
Principal Investigator: William T Abraham, MD Ohio State University
Principal Investigator: Marco A Costa, MD, PhD University Hospitals
  More Information

No publications provided by CardioKinetix, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CardioKinetix, Inc
ClinicalTrials.gov Identifier: NCT01614652     History of Changes
Other Study ID Numbers: VA0956
Study First Received: June 4, 2012
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by CardioKinetix, Inc:
Congestive Heart Failure Due to LV Systolic Dysfunction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014