Heart FailureNCT01076348
Model 4965 Post-Approval Study
An observational study of Heart Failure and Pacing, run by Medtronic at 107 sites in 14 countries.
Trial summary
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Pacing, Bradycardia
- How many people
- 73 participants
- Where
- 107 sitesin 14 countries
- Study dates
- Sep 1996to Apr 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.
Who may be able to join
- Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB
- AND one of the following (A, B, or C) must also apply:
- Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.
- Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:
- product is market-released
- complete implant and follow-up data, including product-related adverse events, are available
- subject or appropriate legal guardian authorizes release of subject study data to SLS C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. Post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead.
- Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic Systems Study will continue in the follow-up phase of the SLS.
Who cannot join
- Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
- Subjects who are, or will be inaccessible for follow-up at a SLS center
- Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
- Subjects with exclusion criteria required by local law (EMEA only)
Trial locations and contacts
107 sites in 14 countries.
107 sites in 14 countries
United States84 sites
Study site
Albuquerque, New Mexico
Study site
Alexandria, Louisiana
Study site
Amarillo, Texas
Study site
Anchorage, Alaska
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bakersfield, California
Study site
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Study site
Browns Mills, New Jersey
Study site
Burlington, Vermont
Study site
Chattanooga, Tennessee
Study site
Chesapeake, Virginia
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, South Carolina
Study site
Columbus, Georgia
Study site
Columbus, Ohio
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Des Moines, Iowa
Study site
Downey, California
Study site
Doylestown, Pennsylvania
Study site
East Palo Alto, California
Study site
Fairfax, Virginia
Study site
Florence, South Carolina
Study site
Fort Worth, Texas
Study site
Germantown, Tennessee
Study site
Grand Blanc, Michigan
Study site
Greensboro, North Carolina
Study site
Hickory, North Carolina
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Lancaster, Pennsylvania
Study site
Lebanon, New Hampshire
Study site
Lexington, Kentucky
Study site
Little Rock, Arkansas
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Marietta, Georgia
Study site
Marquette, Michigan
Study site
Melbourne, Florida
Study site
Memphis, Tennessee
Study site
Milwaukee, Wisconsin
Study site
Mineola, New York
Study site
Nashville, Tennessee
Study site
Newark, New Jersey
Study site
Newburgh, Indiana
Study site
Oak Lawn, Illinois
Study site
Ocala, Florida
Study site
Ocean City, New Jersey
Study site
Olympia, Washington
Study site
Parlin, New Jersey
Study site
Phoenix, Arizona
Study site
Portland, Oregon
Study site
Robbinsdale, Minnesota
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Saginaw, Michigan
Study site
Saint Paul, Minnesota
Study site
Salinas, California
Study site
Salisbury, Maryland
Study site
San Antonio, Texas
Study site
Sayre, Pennsylvania
Study site
Scottsdale, Arizona
Study site
Silver Spring, Maryland
Study site
Sioux Falls, South Dakota
Study site
Southfield, Michigan
Study site
Spokane, Washington
Study site
The Woodlands, Texas
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Towson, Maryland
Study site
Van Nuys, California
Study site
Washington D.C., District of Columbia
Study site
Wellington, Florida
Study site
West Orange, New Jersey
Canada7 sites
Study site
Calgary, Alberta
Study site
Hamilton, Ontario
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Regina, Saskatchewan
Study site
Ste-Foy, Quebec
Study site
Toronto, Ontario
About this study
Official title: Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
Read the detailed description
As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.
- Conditions
- Heart Failure, Pacing, Bradycardia, Arrhythmia
- Keywords
- Epicardial, Pacing Lead
- Medical subject headings
- Heart Failure, Bradycardia, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Model 4965 Complication Free Rate
A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2010 (estimated)
- Study startSep 1996
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 4965 Post-Approval Study Clinical Trial Leader, Study chair, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076348
- Sponsor's protocol ID
- 4965
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2010
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study
- ClinicalTrials.gov ID
- NCT01076348
- Acronym / sponsor ID
- 4965
- Conditions
- Heart Failure, Pacing, Bradycardia, Arrhythmia
- Keywords
- Epicardial, Pacing Lead
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- Sep 1996
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Feb 2010 (estimated)
- Results
- Posted 23 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted within Medtronic's System Longevity Study (SLS).
Detailed description
As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model 4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects 19 years or older implanted with Model 4965 Capsure Epi Lead.
Key inclusion criteria (8 listed)
- Subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's IRB/MEC/REB
- Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic lead must be used for a pacing, sensing, or defibrillation application.
- Subjects who participated in a qualifying study of a Medtronic cardiac therapy product and for whom:
- product is market-released
- complete implant and follow-up data, including product-related adverse events, are available
Key exclusion criteria (4 listed)
- Subjects receiving an implant of a Medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
- Subjects who are, or will be inaccessible for follow-up at a SLS center
- Subjects implanted with a Medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded
- Subjects with exclusion criteria required by local law (EMEA only)
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
Model 4965 Complication Free Rate
Time frame: 1 year
A 4965 lead-related complication is an adverse event requiring invasive intervention to resolve. The complication-free rate is based on the number of leads analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4965 Post-Approval Study Clinical Trial Leader study chair
Medtronic
107 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pacing, run by Medtronic at 107 sites in 14 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 8 inclusion and 4 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in United States, Canada, Italy, Austria, Netherlands and 9 more countries. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Model 4965 Complication Free Rate (time frame: 1 year). 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 27 Feb 2019.