Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients

Heart Failure Clinical Trial

— PARACHUTE  

Official title:

A Feasibility Trial to Evaluate the VPD Implant System - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573560
• Other study ID #: US PARACHUTE Protocol
• Status: Completed
• Phase: Phase 1
• First received: December 12, 2007
• Last updated: June 21, 2017
• Start date: December 2007
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: CardioKinetix, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

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

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

3. NYHA Class at time of enrollment, either:

• NYHA Class III or 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 and = 1 hospitalization for heart failure during 12-month period prior to enrollment

4. LVEF = 40% as measured by echocardiography

5. Left ventricle must have appropriate anatomy as measured by Cardiac CT per the VPD Implant sizing criteria described in the device's Instructions For Use

6. Eligible for cardiac surgery

7. Between 18 and 74 years of age (inclusive)

8. Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment

9. 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

10. Provide written informed consent

11. Agree to the protocol-required follow-up

Exclusion Criteria:

1. Myocardial ischemia requiring PCI or CABG

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 CRT device within 60 days of enrollment

6. Patient diagnosed with significant valve disease (AI >1+; MR >2+) which may or may not require surgery

7. Patient has received an ICD within 60 days of enrollment

8. Patient has received a pacemaker within 60 days of enrollment

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

10. Patients with a history or a current diagnosis of either persistent or paroxysmal atrial fibrillation as well as patients who present with a contraindication to oral anticoagulant therapy

11. Aortic valve replacement or repair

12. Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg

13. Resting heart rate more than 120 bpm

14. Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium

15. History of bleeding diathesis or a major coagulopathy (i.e. platelet count < 100,000 plts/ml whole blood; PTT or PT > 1.3 times control value)

16. GI bleed requiring transfusion within the past 3 months

17. Patient has suffered a stroke within the past 6 months

18. Evidence of severe calcification in the VPD Implant attachment zone

19. Evidence of a significant sub-aortic obstruction ("left moderator band") in the area of implant

20. History of Kawasaki's disease

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

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

23. Patient has chronic liver disease

24. Patient has received intracardiac gene therapy or stem cell therapy

25. Creatinine > 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure

26. Hypersensitivity to contrast media

27. Allergy or contraindication to clopidogrel or aspirin

28. Evidence of ongoing infection (fever with temperature > 38°C and/or WBC > 15,000)

29. 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.)

30. 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

Intervention

Device:
• VPD Implant System
Percutaneous introduction using standard catheterization techniques of the VPD Implant.

Locations

Country	Name	City	State
Serbia	Dedinje Cardiovascular Institute	Belgrade
United States	Mission Hospitals	Asheville	North Carolina
United States	Northwestern University Medical Center	Chicago	Illinois
United States	The Ohio State University	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Texas Heart Institute	Houston	Texas
United States	Washington Hospital Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
CardioKinetix, Inc

Countries where clinical trial is conducted

United States,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.		6 months
Secondary	Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke		12 months