CompletedNot Applicable

Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study

United States50 participantsStarted 2012-05

Plain-language summary

The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signed informed consent form * 16 years of age or older * Supported by HeartMate II LVAD continuously for at least 6 months and not currently hospitalized * Will continue on LVAD support for at least another 30 days * No driveline or systemic infection * Willing and able to perform kit dressing changes at least once every 7 days for 30 days * Can fill out study forms * Can use a digital camera * Willing to return to clinic for final study visit in 30 days Exclusion Criteria: * High risk for non-compliance * Ongoing mechanical circulatory support other than HeartMate II LVAD * Sensitivity to kit components * Skin condition that may react to kit component adhesives * Already using all components of Percutaneous Lead Management Kit

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demonstration of the wearability and usability of the Percutaneous Lead Management Kit

Timeframe: Up to 30 days

Trial details

NCT IDNCT01485666

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Left Ventricular Assist Device trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.