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Heart FailurePhase 1PARACHUTENCT00573560

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

A Phase 1 study testing VPD Implant System in people with Heart Failure, run by CardioKinetix, Inc at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Heart Failure
What is being tested?
VPD Implant System
Type of treatment
Medical device
How many people
20 participants
Where
7 sitesin 2 countries
Study dates
Dec 2007to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)
  • GI bleed requiring transfusion within the past 3 months
  • Patient has suffered a stroke within the past 6 months
  • Evidence of severe calcification in the VPD Implant attachment zone
  • Evidence of a significant sub-aortic obstruction ("left moderator band") in the area of implant
  • History of Kawasaki's disease
  • Patient has received a heart, lung, liver and/or kidney transplant
  • Patient on dialysis or expected to require hemodialysis within 12 months
  • Patient has chronic liver disease
  • Patient has received intracardiac gene therapy or stem cell therapy
  • Creatinine > 2.5mg/dl or impaired renal function that places patient at risk of contrast induced renal failure
  • Hypersensitivity to contrast media
  • Allergy or contraindication to clopidogrel or aspirin
  • Evidence of ongoing infection (fever with temperature > 38°C and/or WBC > 15,000)
  • 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.)
  • Patient is currently participating in another investigational device or drug research study for which the follow-up period is not complete

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States6 sites

  • Mission Hospitals

    Asheville, North Carolina, 28802

  • Northwestern University Medical Center

    Chicago, Illinois, 60611

  • The Ohio State University

    Columbus, Ohio, 43210

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Texas Heart Institute

    Houston, Texas, 77030

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Serbia1 site

  • Dedinje Cardiovascular Institute

    Belgrade, 11040

Other trials in Serbia

About this study

Official title: A Feasibility Trial to Evaluate the VPD Implant System - Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

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
Being tested
VPD Implant System
Keywords
Heart failure, percutaneous, interventional cardiology, apical remodeling, LV dilatation, akinesis, dyskinesis
Medical subject headings
Heart Failure, Dyskinesias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VPD Implant SystemDevice

    Percutaneous introduction using standard catheterization techniques of the VPD Implant.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJan 2010
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00573560
Sponsor's protocol ID
US PARACHUTE Protocol
Acronym
PARACHUTE
Status last verified
Jul 2014
First submitted
12 Dec 2007
Last updated
22 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25037310

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VPD Implant System in people with Heart Failure, run by CardioKinetix, Inc at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00573560, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.

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