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

NCT01297296 | Terminated

• 1 other identifier: RD1051
• Study Type: observational
• Target: 54
• Locations: 6 countries
• Sites: 13

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.

Conditions

Heart Failure; Myocardial Infarction

Keywords

heart failure; percutaneous; interventional cardiology; apical remodeling; LV dilatation; akinesis; dyskinesis; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Left Ventricular Volume Indices

  6 months and annually to 5 years

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
• Subject is not hospitalized at time of enrollment.
• 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
• LVEF \>15 or% and ≤ 40% as measured by echocardiography.
• Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
• Eligible for cardiac surgery
• Between 18 and 79 years of age (inclusive)
• 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
• Provide written informed consent
• Agree to the protocol-required follow-up

You may not qualify if:

• 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

Sponsors & Collaborators

• CardioKinetix, Inc: lead

Study Sites (13)

OLV Hospital Aalst

Aalst, 9300, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Kerckhoff-Klinik SGmbh

Bad Nauheim, 61231, Germany

Location

Arzt St. Marien-Hospital Abt. Innere Medizin

Bonn, 53115, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

University of Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Leipzig

Leipzig, 04289, Germany

Location

Universitat Rostok

Rostock, 18057, Germany

Location

Ferrarotto University Hospital Catania

Catania, 95123, Italy

Location

University Medical Center (UMC) Utrecht

Utrecht, 3508, Netherlands

Location

Hospital Clinico de Barcelona

Barcelona, 08028, Spain

Location

Golden Jubilee Hospital

Glasgow, G81 4DY, United Kingdom

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26499223 DERIVED

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction; Dyskinesias

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Simon Redwood, MD

  St. Thomas' Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

ES (1); IT (1); DE (6); NL (1); BE (2); GB (2)