Heart FailureNCT00869921
Model 4195 Left Ventricular (LV) Lead Chronic Performance Study
An observational study of Heart Failure, run by Medtronic at 67 sites in 3 countries.
Trial summary
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 1,322 participants
- Where
- 67 sitesin 3 countries
- Study dates
- Mar 2009to 3 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients implanted with a 4195 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.
Who may be able to join
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
- Patient within 30 day post implant enrollment window
Who cannot join
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
Trial locations and contacts
67 sites in 3 countries.
67 sites in 3 countries
United States62 sites
Study site
Albany, Georgia
Study site
Albuquerque, New Mexico
Study site
Anchorage, Alaska
Study site
Austin, Texas
Study site
Baton Rouge, Louisiana
Study site
Boston, Massachusetts
Study site
Bradenton, Florida
Study site
Burlington, Vermont
Study site
Chula Vista, California
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Colorado Springs, Colorado
Study site
Columbia, Missouri
Study site
Columbus, Ohio
Study site
Covington, Louisiana
Study site
Dallas, Texas
Study site
Des Moines, Iowa
Study site
Durham, North Carolina
Study site
Edgewood, Kentucky
Study site
Falls Church, Virginia
Study site
Fargo, North Dakota
Study site
Fort Worth, Texas
Study site
Germantown, Tennessee
Study site
Grand Blanc, Michigan
Study site
Henderson, Nevada
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Kingsport, Tennessee
Study site
Lancaster, Pennsylvania
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Marietta, Georgia
Study site
Marquette, Michigan
Study site
Melbourne, Florida
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Newburgh, Indiana
Study site
Olympia, Washington
Study site
Phoenix, Arizona
Study site
Plano, Texas
Study site
Portland, Oregon
Study site
Redding, California
Study site
Robbinsdale, Minnesota
Study site
Rochester, Minnesota
Study site
Saint Louis Park, Minnesota
Study site
Salinas, California
Study site
Salisbury, Maryland
Study site
San Antonio, Texas
Study site
Scottsdale, Arizona
Study site
Silver Spring, Maryland
Study site
Spokane, Washington
Study site
Stanford, California
Study site
Takoma Park, Maryland
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
West Orange, New Jersey
Canada4 sites
Study site
Calgary, Alberta
Study site
Kingston, Ontario
Study site
Ottawa, Ontario
Study site
Québec, Quebec
About this study
Official title: Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.
Read the detailed description
Model 4195 LV lead complication-free survivability will be summarized.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead-related complication rate.
Measured: Implant to 5 years post-implant.
Secondary outcomes (1)
Types of Model 4195 lead-related events
Measured: 5 years post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startMar 2009
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
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.
- More trials run by MedtronicThe 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
- Prospective
- Enrolment
- 1,322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 4195 LV Lead Chronic Performance Study Team, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869921
- Sponsor's protocol ID
- 4195 Chronic Performance
- Status last verified
- Sep 2018
- First submitted
- 25 Mar 2009
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attain StarFix® Model 4195 Left Ventricular Lead Chronic Performance Post Approval Study
- ClinicalTrials.gov ID
- NCT00869921
- Acronym / sponsor ID
- 4195 Chronic Performance
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,322 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 26 Mar 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.
Evaluate long-term performance of the 4195 LV Lead. This evaluation is based on the number of lead-related complications occuring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Model 4195 LV Lead and is integrated within Medtronic's post-market surveillance platform.
Detailed description
Model 4195 LV lead complication-free survivability will be summarized.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients implanted with a 4195 LV Lead within the past 30 days. All patients must meet Inclusion criteria and none of the Exclusion criteria.
Key inclusion criteria (3 listed)
- Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- Patient has or is intended to receive an Attain StarFix Model 4195 LV lead
- Patient within 30 day post implant enrollment window
Key exclusion criteria (3 listed)
- Patient who is, or is expected to be inaccessible for follow-up
- Patient with exclusion criteria required by local law
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound 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
Lead-related complication rate.
Time frame: Implant to 5 years post-implant.
1 secondary outcome
Types of Model 4195 lead-related events
Time frame: 5 years 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 13 Sep 2018.
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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 LV Lead Chronic Performance Study Team study chair
Medtronic
67 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Medtronic at 67 sites in 3 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 3 inclusion and 3 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 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada, United Kingdom. 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?
Lead-related complication rate. (time frame: Implant to 5 years 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 13 Sep 2018.