A Multinational Trial To Evaluate The Parachute Implant System

NCT ID: NCT01286116

Last Updated: 2017-06-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-06-30

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.

Detailed Description

While current therapies for heart failure (including but not limited to: medical management, cardiac resynchronization and ICDs) may represent the best treatment available today for the majority of HF patients, the medical community recognizes that pharmacologic therapy has been optimized to nearly the extent that is possible, and that any incremental improvements in the management of HF patients will now come from device based therapies. With this background, CardioKinetix has developed a catheter-based intravascular approach to ventricular partitioning using an implantable device. The purpose of this study is to assess the safety of using the CardioKinetix Parachute device to isolate the malfunctioning portion of the left ventricle in patients with symptoms of HF due to ischemic heart disease.

Conditions

Heart Failure; Myocardial Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Parachute implant

Group Type: EXPERIMENTAL

Parachute Implant

Intervention Type: DEVICE

Mechanical ventricular partitioning

Interventions

Parachute Implant

Mechanical ventricular partitioning

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region

2. Subject is not hospitalized at time of enrollment.

3. Diagnosis of heart failure for a minimum of 6 months prior to enrollment

4. 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

5. LVEF >15% and ≤ 40% as measured by echocardiography.

6. Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.

7. Eligible for cardiac surgery

8. Between 18 and 79 years of age (inclusive)

9. 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

10. 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

11. Provide written informed consent

12. Agree to the protocol-required follow-up

Exclusion Criteria

Candidates will be excluded from the study if ANY of the following conditions apply:

1. Untreated clinically significant coronary artery disease requiring intervention.

2. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment

3. Cardiogenic shock within 72 hours of enrollment

4. Revascularization procedure (PCI or CABG) within 60 days of enrollment

5. Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment

6. Moderate aortic stenosis and regurgitation (aortic or mitral) >2+.

7. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF

8. 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.

9. Aortic valve replacement or repair

10. Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.

11. Active peptic ulcer or GI bleeding within the past 3 months

12. Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months

13. History of Kawasaki's disease

14. Patient has received a heart, lung, liver and/or kidney transplant

15. Patient on dialysis or expected to require hemodialysis within 12 months

16. Patient has chronic liver disease

17. Impaired renal function that places patient at risk of contrast induced renal failure

18. Ongoing sepsis, including active endocarditis.

19. Co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)

20. Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardioKinetix, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martyn Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

St. Thomas' Hospital

Locations

Hospital of Cardiology Louis Pradel (Lyon)

Bron, , France

Institut Cardiovasculaire Paris-Sud

Massy, , France

University of Heidelberg

Heidelberg, , Germany

Universitat Rostock

Rostock, , Germany

Pauls Stradins Clinical University Hospital

Riga, , Latvia

University of Amsterdam AMC

Amsterdam, , Netherlands

Hospital Santa Marta

Lisbon, , Portugal

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

Clinical Center of Serbia (KCS)

Belgrade, , Serbia

Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)

Ljubljana, , Slovenia

Papworth Hospital

Cambridge, , United Kingdom

St. Thomas' Hospital

London, , United Kingdom

University College of London (The Heart Hospital)

London, , United Kingdom

Countries

France; Germany; Latvia; Netherlands; Portugal; Serbia; Slovenia; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 25037310 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23537969 (View on PubMed)

Other Identifiers

VA0444

Identifier Type: -

Identifier Source: org_study_id