Clinical trial NCT01297296: A Multinational Trial to Evaluate the Longterm Safety of the Parachute Implant System
Official title: PARACHUTE III: A Multinational Trial to Evaluate the Longterm Safety of the Parachute System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Myocardial Infarction
Keywords: heart failure
percutaneous
interventional cardiology
apical remodeling
LV dilatation
akinesis
dyskinesis
myocardial infarction
Lead sponsor: CardioKinetix, Inc
Sponsor class: INDUSTRY
First posted: 2011-02-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.

Brief 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.

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 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Assessment of long term safety of the Parachute system
timeFrame: 5 years
Secondary outcomes:
measure: Change in Left Ventricular Volume Indices
timeFrame: 6 months and annually to 5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik SGmbh
city: Bonn
country: Germany
facility: Arzt St. Marien-Hospital Abt. Innere Medizin
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Rostock
country: Germany
facility: Universitat Rostok
city: Catania
country: Italy
facility: Ferrarotto University Hospital Catania
city: Utrecht
country: Netherlands
facility: University Medical Center (UMC) Utrecht
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Glasgow
country: United Kingdom
facility: Golden Jubilee Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
Study officials:
affiliation: St. Thomas' Hospital
name: Simon Redwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomas M, Nienaber CA, Ince H, Erglis A, Vukcevic V, Schafer U, Ferreira RC, Hardt S, Verheye S, Gama Ribeiro V, Sugeng L, Tamburino C. Percutaneous ventricular restoration (PVR) therapy using the Parachute device in 100 subjects with ischaemic dilated heart failure: one-year primary endpoint results of PARACHUTE III, a European trial. EuroIntervention. 2015 Oct;11(6):710-7. doi: 10.4244/EIJV11I6A143.