NCT01286116

Brief Summary

The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started May 2011

Longer than P75 for phase_3 heart-failure

Geographic Reach
8 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

1.7 years

First QC Date

January 27, 2011

Last Update Submit

June 21, 2017

Conditions

Heart FailureMyocardial Infarction

Keywords

heart failurepercutaneousinterventional cardiologyapical remodelingLV dilatationakinesisdyskinesismyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE)

    Assessment of safety defined as the successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.

    6-months

Secondary Outcomes (1)

  • Change in Left Ventricular Volume Indexes.

    6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Parachute implant

Device: Parachute Implant

Interventions

Parachute ImplantDEVICE

Mechanical ventricular partitioning

Treatment

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
  • Subject is not hospitalized at time of enrollment.
  • Diagnosis of heart failure for a minimum of 6 months prior to enrollment
  • NYHA Class at time of enrollment, either:
  • NYHA Class III or Ambulatory IV - if predominant during the 3-month period prior to enrollment
  • NYHA Class II - if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment
  • LVEF \>15% and ≤ 40% as measured by echocardiography.
  • Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
  • Eligible for cardiac surgery
  • Between 18 and 79 years of age (inclusive)
  • Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
  • Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
  • Provide written informed consent
  • Agree to the protocol-required follow-up

You may not qualify if:

  • Candidates will be excluded from the study if ANY of the following conditions apply:
  • Untreated clinically significant coronary artery disease requiring intervention.
  • Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
  • Cardiogenic shock within 72 hours of enrollment
  • Revascularization procedure (PCI or CABG) within 60 days of enrollment
  • Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
  • Moderate aortic stenosis and regurgitation (aortic or mitral) \>2+.
  • History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
  • A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.
  • Aortic valve replacement or repair
  • Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
  • Active peptic ulcer or GI bleeding within the past 3 months
  • Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
  • History of Kawasaki's disease
  • Patient has received a heart, lung, liver and/or kidney transplant
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hospital of Cardiology Louis Pradel (Lyon)

Bron, 69500, France

Location

Institut Cardiovasculaire Paris-Sud

Massy, 91300, France

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

Universitat Rostock

Rostock, 18057, Germany

Location

Pauls Stradins Clinical University Hospital

Riga, LV1002, Latvia

Location

University of Amsterdam AMC

Amsterdam, 1005 AZ, Netherlands

Location

Hospital Santa Marta

Lisbon, 1169-024, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, 4430-502, Portugal

Location

Clinical Center of Serbia (KCS)

Belgrade, 11000, Serbia

Location

Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)

Ljubljana, 1525, Slovenia

Location

Papworth Hospital

Cambridge, CB23 3RE, United Kingdom

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

University College of London (The Heart Hospital)

London, W1G 8PH, United Kingdom

Location

Related Publications (2)

  • Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18.

    PMID: 25037310DERIVED

  • 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.

    PMID: 23537969DERIVED

MeSH Terms

Conditions

Heart FailureMyocardial InfarctionDyskinesias

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Martyn Thomas, MD

    St. Thomas' Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

January 31, 2011

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2017

Last Updated

June 23, 2017

Record last verified: 2017-06

Locations

DE(2)FR(2)NL(1)GB(3)LA(1)SL(1)PT(2)SE(1)