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Trial record 1 of 8 for:    parachute
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PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. (P5)

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ClinicalTrials.gov Identifier: NCT02543632
Recruitment Status : Terminated (Company closed)
First Posted : September 7, 2015
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
CardioKinetix, Inc

Brief Summary:
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.

Condition or disease Intervention/treatment
Heart Failure Left Ventricular Dysfunction Device: Parachute Implant System

Detailed Description:
Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 85 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: PARACHUTE V: PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE. A German Trial to Evaluate the Improvement in Quality of Life and Cardiac Output Following Implanting of the Parachute Implant System
Study Start Date : August 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treated group
Subjects who meet the inclusion/exclusion criteria listed and also are approved via anatomical inclusion criteria for treatment with the Parachute Implant System.
Device: Parachute Implant System
The CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle.
Other Name: Parachute Device

Control group
Subjects who meet the inclusion/exclusion criteria listed and also are are excluded for treatment with the Parachute Implant System due to anatomical characteristics such as obstructing pseudochordae, calcification, or wall thickness.



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months ]
    An improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline (day -1) using the Minnesota Living with Heart Failure (MLWHF) Questionnaire.


Secondary Outcome Measures :
  1. Stroke Volume Index [ Time Frame: 0 days (at implant) ]
    An improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at least 18 years of age with symptoms of heart failure and anteroapical wall motion abnormality due to myocardial infarction.
Criteria

Inclusion Criteria:

  • Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA)
  • Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%)
  • Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines
  • >18 years of age
  • Provide written informed consent
  • Agree to the protocol-required follow-up

Exclusion Criteria:

  • Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment
  • Cardiogenic shock within 72 hours of enrollment
  • A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated
  • Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy).
  • Co-morbidities associated with a life expectancy of less than 12-months
  • Treatment Arm only (Control Arm excluded from this criteria): Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by magnetic resonance imaging (MRI) or computerized tomography (CT). (Characteristics include inappropriate size and shape of the left ventricle, pseudo chordae or trabeculations interfering with device placement.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543632


Locations
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Germany
Cardiac Research GmbH
Dortmund, Hohe Straße 1, Germany, Dortmund
Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie
Essen, Klara-Kopp-Weg 1, Germany, 45138
Universitätsklinikum Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie
Düsseldorf, Moorenstr. 5, Germany, 40225
Uniklinik Aachen
Aachen, Germany, 52074
Kerckhoff-Klinik gGmbH
Bad Nauheim, Germany, 61231
Unfalkrankenhaus Berlin
Berlin, Germany
University Köln
Cologne, Germany, 50937
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Asklepios Klinik St. George
Hamburg, Germany, 20099
Universitäres Herzzentrum Hamburg Eppendorf GmbH
Hamburg, Germany, 20251
Sponsors and Collaborators
CardioKinetix, Inc
Investigators
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Principal Investigator: Helge Möllmann, MD Kerckhoff Klinik
Additional Information:

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Responsible Party: CardioKinetix, Inc
ClinicalTrials.gov Identifier: NCT02543632    
Other Study ID Numbers: RD1591
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Keywords provided by CardioKinetix, Inc:
heart failure
parachute
partitioning device
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ventricular Dysfunction
Ventricular Dysfunction, Left
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases