Left Ventricular Assist DeviceRESISTNCT01485666
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
An observational study of Left Ventricular Assist Device and Percutaneous Lead Management, run by Abbott Medical Devices at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Left Ventricular Assist Device, Percutaneous Lead Management
- What is being tested?
- Percutaneous Lead Management Kit
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2012to Aug 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Ventricular Assist Device clinic
Who may be able to join
- 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
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- Can fill out study forms
- Can use a digital camera
- Willing to return to clinic for final study visit in 30 days
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Duke University Medical Center
Durham, North Carolina, 27710
University of Rochester Medical Center
Rochester, New York, 14642
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
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.
Read the detailed description
The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.
- Being tested
- Percutaneous Lead Management Kit
- Keywords
- Thoratec, HeartMate II, heart-assist devices, driveline or percutaneous lead management, HeartMate II Percutaneous Lead Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Lead Management KitOther
Also called Thoratec, HeartMate II
A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit
Measured: Up to 30 days
Secondary outcomes (3)
Incidence of adverse reactions to any Percutaneous Lead Management Kit components
Measured: Up to 6 months
Evidence of driveline infection
Measured: Up to 6 months
Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization
Measured: Up to 7 days continuous kit use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Assist DeviceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Pooja Chatterjee, Study director, Thoratec Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485666
- Sponsor's protocol ID
- TC06072011-1
- Acronym
- RESIST
- Status last verified
- Jun 2022
- First submitted
- 1 Dec 2011
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce Driveline Trauma Through Stabilization and Exit Site Management (RESIST) Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT01485666
- Acronym / sponsor ID
- RESIST / TC06072011-1
- Keywords
- Thoratec, HeartMate II, heart-assist devices, driveline or percutaneous lead management, HeartMate II Percutaneous Lead Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Dec 2011 (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 study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.
Detailed description
The Percutaneous Lead Management Kit is a combination of commercially available components that are packaged together in a kit to be used for HeartMate II driveline exit site cleaning, dressing and stabilization. The RESIST study is a prospective, non-randomized study to evaluate the wearability and usability of the Percutaneous Lead Management Kit. Evaluation of the Percutaneous Lead Management Kit for wearability and usability will be performed for 30 days from enrollment. Study patients will also be followed for up to 6 months for any evidence of driveline infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Ventricular Assist Device clinic
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Lead Management KitAlso: Thoratec, HeartMate IIA kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization | Other | – |
Primary outcome
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit
Time frame: Up to 30 days
3 secondary outcomes
Incidence of adverse reactions to any Percutaneous Lead Management Kit components
Time frame: Up to 6 months
Evidence of driveline infection
Time frame: Up to 6 months
Durability of the Percutaneous Lead Management Kit's infection mitigation and stabilization
Time frame: Up to 7 days continuous kit use
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 24 Jun 2022.
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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.
Pooja Chatterjee study director
Thoratec Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Assist Device and Percutaneous Lead Management, run by Abbott Medical Devices at 5 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 9 inclusion and 5 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Demonstration of the wearability and usability of the Percutaneous Lead Management Kit (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2022.