Driveline Silicone Skin Interface Registry (SSI)

March 12, 2019 updated by: Abbott Medical Devices

Driveline Silicone Skin Interface (SSI) Registry

The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale New Haven Hospital
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St.Vincent's Hospital and Health Services
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University - Barnes Jewish Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Medical Center
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Spokane, Washington, United States, 99204
        • Sacred Heart Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications

Description

Inclusion Criteria:

  • Subject has signed the INTERMACS informed consent form
  • Subject has signed the SSI registry informed consent form
  • Subject age ≥ 18 years
  • Subject implanted with a HeartMate II LVAD
  • Subject in whom the full length of the velour portion of the percutaneous lead is fully kept under the skin resulting in a silicone skin interface at the skin exit site
  • In the prospective study cohort, Subject is planned to be supported with the HeartMate II LVAD for at least 12 months
  • In the retrospective study cohort, at the time of enrollment, Subject has been supported with a HeartMate II for at least 10 months

Exclusion Criteria:

  • In the retrospective study cohort, Subject is ongoing with long-term right heart mechanical circulatory support (RVAD)
  • In the retrospective study cohort, Subject had a post-implant sternal re-entry (for bleeding, etc.) or delayed sternal closure
  • In the retrospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
  • In the prospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Control Group
Historical control HeartMate II BTT and DT data
Prospective and Retrospectively identified SSI
Prospectively and Retrospectively identified HeartMate II patients where the full length of the velour coated portion of the driveline is tunneled under the skin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Freedom from DL infection events at 12 months after LVAD implantation
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of subjects with infection events
Time Frame: Month 1, 3, 6, and every six months up to 60 months post-enrollment
Month 1, 3, 6, and every six months up to 60 months post-enrollment
DL infection events per patient year
Time Frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
DL tunneling methods or other factors that might reduce risks of DL related infection events
Time Frame: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
Month 1, 3, 6, and every 6 months up to 60 months post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Thoratec Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Akhter SA, Ewald GA, Walsh MN, et al. Preliminary driveline infection results from the multicenter silicone-skin-interface (SSI) registry. Abstracts from the ASAIO 59th Annual Conference, p. 61. http://journals.lww.com/asaiojournal/Documents/ASAIO%20Abstracts%202013.pdf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TC11282011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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