Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients

NCT00573560 | Completed Phase 1 DMC

• 1 other identifier: US PARACHUTE Protocol
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 7

Brief Summary

The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.

Conditions

Heart Failure

Keywords

Heart failure; percutaneous; interventional cardiology; apical remodeling; LV dilatation; akinesis; dyskinesis

Outcome Measures

Primary Outcomes (1)

• Assessment of safety defined as the successful delivery and deployment of the VPD Implant through 6 month follow up without the occurrence of Major Adverse Cardiac Events (MACE) related to the investigational device.

  6 months

Secondary Outcomes (1)

• Preliminary Effectiveness Measurements at 6 months - Change in LV volume indices (LVESVI, LVEDVI, EF) - Change in 6 minute walk and VO2 max - Cardiovascular mortality and morbidity inclusive of hospitalization for HF, MI and stroke

  12 months

Interventions

VPD Implant System DEVICE

Percutaneous introduction using standard catheterization techniques of the VPD Implant.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
• Diagnosis of heart failure for a minimum of 6 months prior to enrollment
• NYHA Class at time of enrollment, either:
• NYHA Class III or 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 and ≥ 1 hospitalization for heart failure during 12-month period prior to enrollment
• LVEF ≤ 40% as measured by echocardiography
• Left ventricle must have appropriate anatomy as measured by Cardiac CT per the VPD Implant sizing criteria described in the device's Instructions For Use
• Eligible for cardiac surgery
• Between 18 and 74 years of age (inclusive)
• Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment
• Female patients with childbearing potential must have a negative pregnancy test (within 7 days of the procedure) and must agree not to attempt to become pregnant during the course of the study
• Provide written informed consent
• Agree to the protocol-required follow-up

You may not qualify if:

• Myocardial ischemia requiring PCI or CABG
• 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 CRT device within 60 days of enrollment
• Patient diagnosed with significant valve disease (AI \>1+; MR \>2+) which may or may not require surgery
• Patient has received an ICD within 60 days of enrollment
• Patient has received a pacemaker 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
• Patients with a history or a current diagnosis of either persistent or paroxysmal atrial fibrillation as well as patients who present with a contraindication to oral anticoagulant therapy
• Aortic valve replacement or repair
• Resting systolic blood pressure is more than 180 mmHg or less than 90 mmHg
• Resting heart rate more than 120 bpm
• Cardiac CT or echocardiographic evidence of thrombus in the left ventricle or left atrium
• History of bleeding diathesis or a major coagulopathy (i.e. platelet count \< 100,000 plts/ml whole blood; PTT or PT \> 1.3 times control value)

Sponsors & Collaborators

• CardioKinetix, Inc: lead

Study Sites (7)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

Mission Hospitals

Asheville, North Carolina, 28802, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Dedinje Cardiovascular Institute

Belgrade, 11040, Serbia

Location

Related Publications (1)

• Costa MA, Mazzaferri EL Jr, Sievert H, Abraham WT. Percutaneous ventricular restoration using the parachute device in patients with ischemic heart failure: three-year outcomes of the PARACHUTE first-in-human study. Circ Heart Fail. 2014 Sep;7(5):752-8. doi: 10.1161/CIRCHEARTFAILURE.114.001127. Epub 2014 Jul 18.

  PMID: 25037310 DERIVED

MeSH Terms

Conditions

Heart Failure; Dyskinesias

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William T Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: December 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2014
• Last Updated: June 22, 2017

Record last verified: 2014-07

Locations

US (6); SE (1)