Heart FailureNCT00893386
Attain StarFix® 4195 Lead Extraction Study
An observational study of Heart Failure and Indications for Lead Removal, run by Medtronic Cardiac Rhythm and Heart Failure at 24 sites in 2 countries.
Trial summary
The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Indications for Lead Removal
- What is being tested?
- LV Lead Extraction
- Type of treatment
- Surgery or procedure
- How many people
- 227 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Jul 2009to Apr 2015
- 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: Patients will be chosen by investigators participating in the study at up to 25 experienced extraction centers throughout the United States and Canada. Patients of both genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria may be in the study.
Who may be able to join
- Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
- Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
- Intention to remove the LV lead prior to the extraction procedure
- Subject is 18 years of age or older
- Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol
Who cannot join
- None
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States21 sites
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Boston, Massachusetts
Study site
Burbank, California
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Durham, North Carolina
Study site
Houston, Texas
Study site
Kansas City, Kansas
Study site
Long Beach, California
Study site
Miami, Florida
Study site
Nashville, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Saint Paul, Minnesota
Study site
Spokane, Washington
Study site
St Louis, Missouri
Canada3 sites
Study site
Ottawa, Ontario
Study site
Sainte-Foy, Quebec
Study site
Toronto, Ontario
About this study
Official title: Attain StarFix® Model 4195 LV Lead Extraction Study
The purpose of this study is to characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.
- Conditions
- Heart Failure, Indications for Lead Removal
- Being tested
- LV Lead Extraction
- Keywords
- Extraction, Removal, Lead, Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV Lead ExtractionProcedure or surgery
Removal of a LV lead using any tools \& techniques.
| Study group | Role | What they receive |
|---|---|---|
| Non-4195 Lead, 181 days | Patients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days Receives: Procedure: LV Lead Extraction | |
| 4195 Lead, 181 days | Patients with a Medtronic Model 4195 LV Lead implanted at least 181 days Receives: Procedure: LV Lead Extraction | |
| 4195 Lead, 90-180 days | Patients with Medtronic Model 4195 LV Lead implanted for 90-180 days Receives: Procedure: LV Lead Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Removal success of LV leads implanted for more than 180 days
Measured: More than 180 days post-implant
Secondary outcomes (4)
Success of lead removal by how long the lead has been implanted
Measured: More than 180 days post-implant
Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool.
Measured: 0 to 45 days post-lead extraction
Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days
Measured: 90 -180 days post-implant
Summary of tools & techniques used to remove LV leads.
Measured: More than 180 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 4195 Extraction Study Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893386
- Sponsor's protocol ID
- StarFix Extraction
- Status last verified
- Jan 2016
- First submitted
- 28 Apr 2009
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attain StarFix® Model 4195 LV Lead Extraction Study
- ClinicalTrials.gov ID
- NCT00893386
- Acronym / sponsor ID
- StarFix Extraction
- Conditions
- Heart Failure, Indications for Lead Removal
- Keywords
- Extraction, Removal, Lead, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 May 2009 (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 characterize the removability of the Attain StarFix® Model 4195 Left Ventricular (LV) Lead (StarFix®). The goal of the trial is to evaluate the lead removal success in patients that are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA) as a condition of approval for the Attain StarFix® Model 4195 LV Lead.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-4195 Lead, 181 days | – | Procedure: LV Lead ExtractionPatients with a Medtronic LV Lead, other than Model 4195, implanted at least 181 days |
| 4195 Lead, 181 days | – | Procedure: LV Lead ExtractionPatients with a Medtronic Model 4195 LV Lead implanted at least 181 days |
| 4195 Lead, 90-180 days | – | Procedure: LV Lead ExtractionPatients with Medtronic Model 4195 LV Lead implanted for 90-180 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be chosen by investigators participating in the study at up to 25 experienced extraction centers throughout the United States and Canada. Patients of both genders that are indicated for a Model 4195 or a non-Model 4195 Medtronic lead extraction who meet all inclusion criteria may be in the study.
Key inclusion criteria (5 listed)
- Subjects with a Class I/II indication and/or physician discretion for left ventricular lead removal
- Medtronic Model 4195 LV lead implanted for at least 181 days at time of extraction, or other Medtronic LV Lead (non-Model 4195) implanted for at least 181 days at time of extraction, or Medtronic Model 4195 LV lead implanted for 90-180 days
- Intention to remove the LV lead prior to the extraction procedure
- Subject is 18 years of age or older
- Subject (or subject's legally authorized representative) has signed and dated the Patient Consent Form and is willing and able to comply with the protocol
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| LV Lead ExtractionRemoval of a LV lead using any tools \& techniques. | Procedure or surgery | 4195 Lead, 181 days, 4195 Lead, 90-180 days, Non-4195 Lead, 181 days |
Primary outcome
Removal success of LV leads implanted for more than 180 days
Time frame: More than 180 days post-implant
4 secondary outcomes
Success of lead removal by how long the lead has been implanted
Time frame: More than 180 days post-implant
Adverse Events that are related to the LV lead, the extraction procedure, or the extraction tool.
Time frame: 0 to 45 days post-lead extraction
Removal success of Medtronic Model 4195 LV Leads implanted for 90-180 days
Time frame: 90 -180 days post-implant
Summary of tools & techniques used to remove LV leads.
Time frame: More than 180 days post-implant
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 1 Feb 2016.
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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.
4195 Extraction Study Team study chair
Medtronic
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Indications for Lead Removal, run by Medtronic Cardiac Rhythm and Heart Failure at 24 sites in 2 countries.
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 5 inclusion and 1 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. 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?
Removal success of LV leads implanted for more than 180 days (time frame: More than 180 days post-implant). 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 1 Feb 2016.