A Multinational Trial To Evaluate The Parachute Implant System

Heart Failure Clinical Trial

— PARACHUTE  

Official title:

A MULTINATIONAL TRIAL TO EVALUATE THE PARACHUTE IMPLANT SYSTEM: PARACHUTE PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01286116
• Other study ID #: VA0444
• Status: Terminated
• Phase: Phase 3
• First received: January 27, 2011
• Last updated: June 21, 2017
• Start date: May 2011
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: CardioKinetix, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: June 2017
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Candidates for this study must meet ALL of the following 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

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Device:
• Parachute Implant
Mechanical ventricular partitioning

Locations

Country	Name	City	State
France	Hospital of Cardiology Louis Pradel (Lyon)	Bron
France	Institut Cardiovasculaire Paris-Sud	Massy
Germany	University of Heidelberg	Heidelberg
Germany	Universitat Rostock	Rostock
Latvia	Pauls Stradins Clinical University Hospital	Riga
Netherlands	University of Amsterdam AMC	Amsterdam
Portugal	Hospital Santa Marta	Lisbon
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Serbia	Clinical Center of Serbia (KCS)	Belgrade
Slovenia	Ljubljana University Medical Center (Univerzitetni Klinicni Center Ljubljana)	Ljubljana
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	St. Thomas' Hospital	London
United Kingdom	University College of London (The Heart Hospital)	London

Sponsors (1)

Lead Sponsor	Collaborator
CardioKinetix, Inc

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Left Ventricular Volume Indexes.	Change in Left Ventricular Volume Indexes including End Systolic {LVESVI} and End Diastolic {LVEDVI}) measured by echocardiography from baseline to 6 months	6 months