Heart FailureNCT02294331
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study
An observational study of Heart Failure, run by Medtronic at 100 sites in 8 countries.
Trial summary
Lead survivability will be summarized. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 1,900 participants
- Where
- 100 sitesin 8 countries
- Study dates
- Aug 2014to 31 Jul 2021
- Phase
- Observational
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 an Attain Performa™ LV Lead within 30 days. All subjects 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 Performa™ 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
100 sites in 8 countries.
100 sites in 8 countries
United States81 sites
Study site
Akron, Ohio, 44304
Study site
Albany, Georgia, 31701
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Albuquerque, New Mexico, 87106
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Allentown, Pennsylvania, 18103
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Anchorage, Alaska, 99508
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Austin, Texas, 78705
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Bakersfield, California, 93301
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Baton Rouge, Louisiana, 70808
St Luke's University Health Network
Bethlehem, Pennsylvania
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Birmingham, Alabama, 35294
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Bradenton, Florida, 34205
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Burlington, Vermont, 05401
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Chandler, Arizona, 85226
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Charlotte, North Carolina, 28203
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Cincinnati, Ohio, 45219
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44195
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Colorado Springs, Colorado, 80907
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Columbia, Missouri, 65201
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Dallas, Texas, 75226
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Danville, Pennsylvania, 17822
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Durham, North Carolina, 27705
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Edgewood, Kentucky, 41017
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Erie, Pennsylvania, 16550
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Evansville, Indiana, 47710
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Falls Church, Virginia, 22042
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Fort Worth, Texas, 76104
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Germantown, Tennessee, 38138
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Gilbert, Arizona, 85295
Hattiesburg Clinic
Hattiesburg, Mississippi
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Houston, Texas, 77030
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Huntington, New York, 11743
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Hyattsville, Maryland, 20782
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Jacksonville, Florida, 32216
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Jonesboro, Arkansas, 72410
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64111
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Lakewood, Colorado, 80228
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Lansing, Michigan, 48912
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Las Vegas, Nevada, 89169
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Lebanon, New Hampshire, 03766
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Leesburg, Virginia, 20176
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Lexington, Kentucky, 40503
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Louisville, Kentucky, 40207
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Madison, Wisconsin, 53715
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Marietta, Georgia, 30060
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Marquette, Michigan, 49855
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Milwaukee, Wisconsin, 53215
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Minneapolis, Minnesota, 55407
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Morristown, New Jersey, 07960
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Nashville, Tennessee, 37203
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New Haven, Connecticut, 06519
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New York, New York, 10032
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Philadelphia, Pennsylvania, 19104
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Pittsburgh, Pennsylvania, 15213
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Plano, Texas, 75093
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Portland, Oregon, 97220
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Poughkeepsie, New York, 12601
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Raleigh, North Carolina, 27610
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Rancho Mirage, California, 92270
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Redwood City, California, 94062
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Robbinsdale, Minnesota, 55422
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Rochester, Minnesota, 554905
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Safety Harbor, Florida, 34695
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Salinas, California, 93901
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Salisbury, Maryland, 21804
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San Diego, California, 92103
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Silver Spring, Maryland, 20910
Study site
Spokane, Washington, 99204
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St Louis, Missouri, 63110
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Stanford, California, 94305
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Takoma Park, Maryland, 20912
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The Woodlands, Texas, 77384
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Toledo, Ohio, 43608
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Torrance, California, 90503
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Utica, New York, 13501
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Van Nuys, California, 91405
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Washington D.C., District of Columbia, 20010
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West Des Moines, Iowa, 50266
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Wilkes-Barre, Pennsylvania, 18711
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Ypsilanti, Michigan, 48197
Canada6 sites
Study site
Calgary, Alberta
Study site
Calgary
Study site
London, Ontario
Study site
Montreal, Quebec
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Ottawa
Study site
Québec, Quebec
Netherlands4 sites
Study site
Eindhoven
Study site
Maastricht
Study site
Nieuwegein
Study site
Rotterdam
About this study
Official title: Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study
Lead survivability will be summarized.
Read the detailed description
The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. This evaluation is based on the number of lead-related complications occurring 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 Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Attain Performa™ LV Leads | Patients who meet all Inclusion criteria and no Exclusion criteria and are implanted with an Attain Performa™ LV lead. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead complication
Survival analysis will be used to analyze the lead. Lead status will be reported as a function of time post-implant for all leads in the study.
Lead related complications include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
Measured: 5 years
Secondary outcomes (3)
Types of lead-related adverse device effects
Summary statistics will be used to report types and rates of lead related adverse device effects (ADE). Examples of ADEs include but are not limited to: failure to capture, abnormal sensing, threshold rise, abnormal impedance, insulation breach, conductor fracture, extracardiac stimulation, lead dislodgement, cardiac perforation, structural lead failure.
Measured: 5 years
Returned lead analysis
A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.
Measured: 5 years
Lead survival estimate by model
An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startAug 2014
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
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
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294331
- Sponsor's protocol ID
- Attain Performa™ PAS
- Status last verified
- Jan 2022
- First submitted
- 8 Oct 2014
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No