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

21. juni 2017 oppdatert av: CardioKinetix, Inc

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

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.

Studieoversikt

Status

Avsluttet

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Belgia
- - Aalst, Belgia, 9300
    - OLV Hospital Aalst
  - Antwerpen, Belgia, 2020
    - ZNA Middelheim
Italia
- - Catania, Italia, 95123
    - Ferrarotto University Hospital Catania
Nederland
- - Utrecht, Nederland, 3508
    - University Medical Center (UMC) Utrecht
Spania
- - Barcelona, Spania, 08028
    - Hospital Clínico de Barcelona
Storbritannia
- - Glasgow, Storbritannia, G81 4DY
    - Golden Jubilee Hospital
  - London, Storbritannia, SE1 7EH
    - St. Thomas' Hospital
Tyskland
- - Bad Nauheim, Tyskland, 61231
    - Kerckhoff-Klinik SGmbh
  - Bonn, Tyskland, 53115
    - Arzt St. Marien-Hospital Abt. Innere Medizin
  - Hamburg, Tyskland, 20099
    - Asklepios Klinik St. Georg
  - Heidelberg, Tyskland, 69120
    - University of Heidelberg
  - Leipzig, Tyskland, 04289
    - University Hospital Leipzig
  - Rostock, Tyskland, 18057
    - Universitat Rostok

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 79 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population will be open to all individuals who meet the inclusion/exclusion criteria. This is a prospective, multi-center, non-randomized trial.

Beskrivelse

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:

Untreated clinically significant coronary artery disease requiring intervention.
Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
Cardiogenic shock within 72 hours of enrollment
Revascularization procedure (PCI or CABG) within 60 days of enrollment
Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
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.
Aortic valve replacement or repair
Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
Active peptic ulcer or GI bleeding within the past 3 months
Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
History of Kawasaki's disease
Patient on dialysis or expected to require hemodialysis within 12 months
Patient has chronic liver disease
Impaired renal function that places patient at risk of contrast induced renal failure
Ongoing sepsis, including active endocarditis.
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.)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Assessment of long term safety of the Parachute system Tidsramme: 5 years	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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in Left Ventricular Volume Indices Tidsramme: 6 months and annually to 5 years	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CardioKinetix, Inc

Etterforskere

Hovedetterforsker: Simon Redwood, MD, St. Thomas' Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2011

Primær fullføring (Faktiske)

1. juni 2014

Studiet fullført (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først innsendt

15. februar 2011

Først innsendt som oppfylte QC-kriteriene