Driveline Heart-assisted Device Related InfectionSSINCT01577433
Driveline Silicone Skin Interface Registry
An observational study of Driveline Heart-assisted Device Related Infection, run by Abbott Medical Devices at 15 sites in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Driveline Heart-assisted Device Related Infection
- How many people
- 400 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2012to Dec 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Chicago Medical Center
Chicago, Illinois, 60637
Baylor Medical Center
Dallas, Texas, 75226
Henry Ford Hospital
Detroit, Michigan, 48202
St.Vincent's Hospital and Health Services
Indianapolis, Indiana, 46260
University of Iowa Hospital
Iowa City, Iowa, 52242
Abbott Northwestern
Minneapolis, Minnesota, 55407
Intermountain Medical Center
Murray, Utah, 84107
Yale New Haven Hospital
New Haven, Connecticut, 06520
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Virginia Commonwealth University
Richmond, Virginia, 23298
Sacred Heart Medical Center
Spokane, Washington, 99204
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: 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)
- Keywords
- HeartMate II, heart-assist device, left ventricular assist device, driveline infection, LVAD, HMII LVAS driveline, silicone portion, Thoratec Corporation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Freedom from DL infection events at 12 months after LVAD implantation
Measured: 12 Months
Secondary outcomes (3)
Percentage of subjects with infection events
Measured: Month 1, 3, 6, and every six months up to 60 months post-enrollment
DL infection events per patient year
Measured: 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
Measured: Month 1, 3, 6, and every 6 months up to 60 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Driveline Heart-assisted Device Related InfectionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- David Farrar, PhD, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577433
- Sponsor's protocol ID
- TC11282011
- Acronym
- SSI
- Status last verified
- Mar 2019
- First submitted
- 11 Apr 2012
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driveline Silicone Skin Interface (SSI) Registry
- ClinicalTrials.gov ID
- NCT01577433
- Acronym / sponsor ID
- SSI / TC11282011
- Keywords
- HeartMate II, heart-assist device, left ventricular assist device, driveline infection, LVAD, HMII LVAS driveline, silicone portion, Thoratec Corporation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- May 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are implanted/have been implanted with the commercially available HeartMate II LVAD for approved indications
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from DL infection events at 12 months after LVAD implantation
Time frame: 12 Months
3 secondary outcomes
Percentage of subjects with infection events
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- BackgroundAkhter 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Farrar, PhD study director
Abbott Medical Devices
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Driveline Heart-assisted Device Related Infection, run by Abbott Medical Devices at 15 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 7 inclusion and 4 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 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
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?
Freedom from DL infection events at 12 months after LVAD implantation (time frame: 12 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 NCT01577433, 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 13 Mar 2019.