A Multinational Trial to Evaluate the Longterm Safety of the Parachute Implant System

Heart Failure Clinical Trial

— PARACHUTEIII  

Official title:

PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01297296
• Other study ID #: RD1051
• Status: Terminated
• Phase: N/A
• First received: February 15, 2011
• Last updated: June 21, 2017
• Start date: July 2011
• Est. completion date: June 2017

Study information

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

Clinical Trial Summary

The primary objective is to assess the longterm 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 longterm 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: 54
• Est. completion date: June 2017
• Est. primary completion date: June 2014
• 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. 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

4. LVEF >15 or% and = 40% as measured by echocardiography.

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

6. Eligible for cardiac surgery

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

8. 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

9. Provide written informed consent

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

7. 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.

8. Aortic valve replacement or repair

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

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

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

12. History of Kawasaki's disease

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

14. Patient has chronic liver disease

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

16. Ongoing sepsis, including active endocarditis.

17. 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.)

Related Conditions & MeSH terms

• Heart Failure
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
Belgium	OLV Hospital Aalst	Aalst
Belgium	ZNA Middelheim	Antwerpen
Germany	Kerckhoff-Klinik SGmbh	Bad Nauheim
Germany	Arzt St. Marien-Hospital Abt. Innere Medizin	Bonn
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	University of Heidelberg	Heidelberg
Germany	University Hospital Leipzig	Leipzig
Germany	Universitat Rostok	Rostock
Italy	Ferrarotto University Hospital Catania	Catania
Netherlands	University Medical Center (UMC) Utrecht	Utrecht
Spain	Hospital Clinico de Barcelona	Barcelona
United Kingdom	Golden Jubilee Hospital	Glasgow
United Kingdom	St. Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
CardioKinetix, Inc

Countries where clinical trial is conducted

Belgium,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of long term safety of the Parachute system	Assessment of long term safety as measured by site-reported device related MACE in real in real-world use of the Parachute Implant through 5 years of clinical follow-up.	5 years
Secondary	Change in Left Ventricular Volume Indices	Change in Left Ventricular Volume Indexes (End Systolic {LVESVI} and End Diastolic {LVEDVI}) as measured by echocardiography from baseline to 6 months and annually to 5 years	6 months and annually to 5 years