PARACHUTE III Pressure Volume Loop Sub-Study

NCT02241837 | Terminated

• 1 other identifier: RD1051.B.3
• Study Type: observational
• Target: 11
• Locations: 3 countries
• Sites: 3

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. This sub-study has the additional assessment of improvement in Pressure Volume Loop and corresponding MSCT to allow improved monitoring of heart improvement after therapy. The PV Loop Substudy studies he effects of the Parachute Implant on pressure and volume as functional parameters of the Left Ventricle.

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 from baseline to 1 year and annually

  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 between baseline, 6 months, and annually

  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 (3)

OLV Hospital Aalst

Aalst, 9300, Belgium

Location

Ferrarotto University Hospital Catania

Catania, 95123, Italy

Location

St. Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

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: September 12, 2014
• First Posted: September 16, 2014
• Study Start: November 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

BE (1); IT (1); GB (1)