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Heart Failure, CongestivePhase 1PEERLESS-HFNCT00291551

Paracor Ventricular Support System (PVSS) for Patients With Heart Failure

A Phase 1 study testing Placement of the PVSS Implant in people with Heart Failure, Congestive, run by Paracor Medical, Inc at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Placement of the PVSS Implant
Type of treatment
Medical device
How many people
39 participants
Where
12 sitesUnited States
Study dates
Jan 2005to Apr 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NYHA functional class II or III
  • Best medical therapy
  • Ejection fraction <= 35%

Who cannot join

  • Heart measurements too large or small for implant sizes
  • Intra-cardiac thrombus
  • Restrictive cardiomyopathy
  • Not a candidate for sternotomy
  • Expected adhesions
  • Previous coronary artery bypass graft (CABG)
Show all 9Show fewer
  • Active infection
  • Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months
  • Myocardial infarction (MI) within 1 month

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham, Division of Cardiovascular Disease

    Birmingham, Alabama, 35294

  • The Ohio State University Heart Center

    Columbus, Ohio, 43210

  • University of Colorado, Health Sciences Center

    Denver, Colorado, 80262

  • University of Florida, Division of Cardiology

    Gainesville, Florida, 32610

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • The Methodist Hospital

    Houston, Texas, 77030

  • Mid America Heart Institute

    Kansas City, Missouri, 64111

  • BryanLGH Heart Institute

    Lincoln, Nebraska, 68506

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

Other trials in United States

About this study

Official title: Paracor Ventricular Support System: United States Clinical Investigational Plan

This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.

No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.

Read the detailed description

Please refer to brief summary.

Being tested
Placement of the PVSS Implant
Medical subject headings
Heart Failure

What participants receive

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

  • Placement of the PVSS ImplantDevice

    Also called HeartNet, Ventricular support device, Ventricular elastic support therapy

    Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.

What is being measured

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

  1. Death or Additional Surgical Session at 6 Months

    Measured: 6 months

Secondary outcomes (11)

  1. Implant Success (Number of Participants Successfully Implanted)

    "Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.

    Measured: 1 day

  2. Change in NYHA Functional Class

    Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remains the same as baseline. "Improved" means the participant's functional class has improved (become lower in number) by at least one class. "Worsened" means the participatn's functional class has deteriorated (become higher in number) by at least one class.

    Measured: Baseline to 6 months

  3. Changes in Left Ventricular Diameters

    Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)

    Measured: Baseline to 6 months

  4. Changes in Left Ventricular Volumes

    Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)

    Measured: Baseline to 6 months

  5. Change in Left Ventricular Ejection Fraction

    Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)

    Measured: Baseline to 6 months

  6. Change in Left Ventricular Mass

    Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)

    Measured: Baseline to 6 months

  7. Changes in 6 Minute Walk

    Mean change in 6 minute walk distance (meters) between baseline and 6 months

    Measured: Baseline to 6 months

  8. Changes in Cardiopulmonary Tests

    Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months

    Measured: Baseline to 6 months

  9. Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score

    The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.

    Measured: Baseline to 6 months

  10. Number of Adverse Events

    Total adverse events reported prior to study closure

    Measured: Study duration

  11. Number of Participants Who Died

    Total number of patient deaths reported prior to study closure

    Measured: Study duration

Timeline

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

  1. First posted14 Feb 2006 (estimated)
  2. Study startJan 2005
  3. Primary completionApr 2007
  4. Study completionApr 2011

Why it stopped: Resources unavailable to continue study follow-up.

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291551
Sponsor's protocol ID
102.1
Acronym
PEERLESS-HF
Status last verified
May 2012
First submitted
10 Feb 2006
Last updated
21 May 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Placement of the PVSS Implant in people with Heart Failure, Congestive, run by Paracor Medical, Inc at 12 sites in United States.

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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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?

Yes. Results are posted in the registry (first posted 10 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Death or Additional Surgical Session at 6 Months (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 NCT00291551.

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 21 May 2012.

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