Driveline Silicone Skin Interface Registry

Completed

• Conditions: Driveline Heart-assisted Device Related Infection

• Registration Number: NCT01577433
• Lead Sponsor: Abbott Medical Devices

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-11
• Study First Submitted QC: 2012-04-12
• Study First Posted: 2012-04-13
• Study Start: 2012-05
• Primary Completion: 2018-07
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from DL infection events at 12 months after LVAD implantation	12 Months

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with infection events	Month 1, 3, 6, and every six months up to 60 months post-enrollment
DL infection events per patient year	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	Month 1, 3, 6, and every 6 months up to 60 months post-enrollment

Trial Locations

Locations (15)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Advocate Christ Medical Center; 🇺🇸 Oak Lawn, Illinois, United States

St.Vincent's Hospital and Health Services; 🇺🇸 Indianapolis, Indiana, United States

University of Iowa Hospital; 🇺🇸 Iowa City, Iowa, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Abbott Northwestern; 🇺🇸 Minneapolis, Minnesota, United States

Washington University - Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

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