Heart FailureNCT01751022
Attain Performa(TM) Quadripolar Lead Study
A study testing Device: Attain Performa Pacing Lead (along with a standard CRT-D system) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 121 sites in 27 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,202 participants
- Where
- 121 sitesin 27 countries
- Study dates
- Dec 2012to Feb 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines)
- Patient (or legally authorized representative) has signed and dated the study-specific Consent Form
- Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
- Patient is expected to remain available for follow-up visits
- Patient understands the study and agrees to comply with study protocol
Who cannot join
- Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
- Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
- Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study)
- Patient is contraindicated for < 1 mg dexamethasone acetate
- Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager)
- Patient has a life expectancy less than 180 days
Show all 9Show fewer
- Patient with exclusion criteria required by local law (e.g. age, pregnancy, breast feeding, etc.)
- In US, women of childbearing potential must have a negative pregnancy test 7 days prior to implant to be included
- Patient is unable to tolerate an urgent thoracotomy
Trial locations and contacts
121 sites in 27 countries.
121 sites in 27 countries
United States67 sites
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Atlantis, Florida
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Austin, Texas
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Baltimore, Maryland
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Boca Raton, Florida
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Boston, Massachusetts
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Burlington, Virginia
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Charlotte, North Carolina
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Chicago, Illinois
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Cleveland, Ohio
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Columbus, Ohio
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Dallas, Texas
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Durham, North Carolina
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Edgewood, Kentucky
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Erie, Pennsylvania
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Fairfax, Virginia
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Fargo, North Dakota
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Fort Lauderdale, Florida
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Germantown, Tennessee
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Glendale, California
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Greenville, South Carolina
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Hartford, Connecticut
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Henderson, Nevada
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Houma, Louisiana
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Houston, Texas
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Jacksonville, Florida
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Kansas City, Kansas
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Kansas City, Missouri
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Kingsport, Tennessee
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Lancaster, Pennsylvania
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Lansing, Michigan
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Lincoln, Nebraska
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Maywood, Illinois
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Medford, Oregon
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Morgantown, West Virginia
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Morristown, New Jersey
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Nashville, Tennessee
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New York, New York
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Norfolk, Virginia
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Oklahoma City, Oklahoma
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Orlando, Florida
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Pittsburgh, Pennsylvania
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Plano, Texas
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Ridgewood, New Jersey
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Riverside, California
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Rockville, Maryland
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Royal Oak, Michigan
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Saint Cloud, Minnesota
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Saint Louis Park, Minnesota
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San Diego, California
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San Jose, California
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Spartanburg, South Carolina
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St Louis, Missouri
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Standford, California
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Stony Brook, New York
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Tampa, Florida
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Temple, Texas
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Tulsa, Oklahoma
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Tupelo, Mississippi
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West Des Moines, Iowa
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West Hollywood, California
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Wilkes-Barre, Pennsylvania
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Winston-Salem, North Carolina
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Wynnewood, Pennsylvania
Germany6 sites
Study site
Bad Rothenfelde
Study site
Bernau
Study site
Bielefeld
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Chemnitz
Study site
Heidelberg
Study site
Trier
Australia5 sites
Study site
Adelaide, South Australia
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Chermside, Queensland
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Heidelberg, Victoria
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Perth, Western Australia
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Randwick, New South Wales
Canada5 sites
Study site
Calgary
Study site
London
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Montreal
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Newmarket
Study site
Québec
Netherlands3 sites
Study site
Eindhoven
Study site
Maastricht
Study site
Nieuwegein
United Kingdom3 sites
Study site
Bournemouth
Study site
London
Study site
Manchester
About this study
The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
- Conditions
- Heart Failure
- Being tested
- Device: Attain Performa Pacing Lead (along with a standard CRT-D system)
- Keywords
- heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Attain Performa Pacing Lead (along with a standard CRT-D system)Device
Implant and follow-up of study lead, separate analysis for each lead model
| Study group | Role | What they receive |
|---|---|---|
| Attain Performa LV Lead (Models 4298, 4398, 4598) | Experimental | N/A: single arm study, separate analysis for each lead model (total of 3). Receives: Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead Complication-free Rate at 6 Months
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:
- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).
- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.
The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.
Measured: Implant to 6 months post-implant
LV Pacing Capture Thresholds Per Attain Performa Lead Model
Measured: 6 months post-implant
Secondary outcomes (7)
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.
Measured: 6 months post-implant
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
Measured: Implant up to 1-month post implant
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Measured: Implant up to 1-month post implant
Pacing Capture Thresholds at the Final Programmed Pacing Polarity
Measured: 6 months post-implant
Implant Related Times Per Attain Performa Lead Model
Measured: Implant up to 1-month post implant
Pacing Impedance at the Final Programmed Pacing Polarity
Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.
Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).
Measured: 6 month post-implant
Complication Rate for Individual Attain Performa Lead Related Events
Measured: 6 month post-Implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751022
- Sponsor's protocol ID
- Attain Performa(TM)
- Status last verified
- Oct 2016
- First submitted
- 3 Dec 2012
- Last updated
- 5 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attain Performa(TM) Quadripolar Lead Study
- ClinicalTrials.gov ID
- NCT01751022
- Acronym / sponsor ID
- Attain Performa(TM)
- Conditions
- Heart Failure
- Keywords
- heart failure, cardiac pacing, cardiac resynchronization therapy, left ventricular lead
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,202 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 5 Dec 2016
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 the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attain Performa LV Lead (Models 4298, 4398, 4598) | Experimental | Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)N/A: single arm study, separate analysis for each lead model (total of 3). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is indicated for implant of a CRT-D device and left-heart lead per local indications (In US only this is based on Class I and II indications for CRT-D implant per HRS/ACC/AHA guidelines)
- Patient (or legally authorized representative) has signed and dated the study-specific Consent Form
- Patient is 18 years of age or older, or is of legal age to give informed consent per local and national law
- Patient is expected to remain available for follow-up visits
- Patient understands the study and agrees to comply with study protocol
Key exclusion criteria (9 listed)
- Patient has a previous LV lead implanted or previous implant attempt within 30 days of enrollment or has ongoing AEs from a previous unsuccessful implant attempt
- Patient has contraindications for standard transvenous cardiac pacing (e.g., mechanical right heart valve)
- Patient has had a heart transplant (Note: Patients waiting for heart transplants are allowed in the study)
- Patient is contraindicated for < 1 mg dexamethasone acetate
- Patient is currently enrolled or planning to participate in a potentially confounding drug or device study during the course of this study. (Note: Co-enrollment in concurrent studies may be allowed provided that documented pre-approval is obtained from Medtronic's study manager)
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 |
|---|---|---|
| Device: Attain Performa Pacing Lead (along with a standard CRT-D system)Implant and follow-up of study lead, separate analysis for each lead model | Device | Attain Performa LV Lead (Models 4298, 4398, 4598) |
Primary outcome
Lead Complication-free Rate at 6 Months
Time frame: Implant to 6 months post-implant
The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: - Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%). - Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months. The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.
LV Pacing Capture Thresholds Per Attain Performa Lead Model
Time frame: 6 months post-implant
7 secondary outcomes
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities
Time frame: 6 months post-implant
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model
Time frame: Implant up to 1-month post implant
Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model
Time frame: Implant up to 1-month post implant
Pacing Capture Thresholds at the Final Programmed Pacing Polarity
Time frame: 6 months post-implant
Implant Related Times Per Attain Performa Lead Model
Time frame: Implant up to 1-month post implant
Pacing Impedance at the Final Programmed Pacing Polarity
Time frame: 6 month post-implant
Complication Rate for Individual Attain Performa Lead Related Events
Time frame: 6 month post-Implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
121 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Attain Performa Pacing Lead (along with a standard CRT-D system) in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 121 sites in 27 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 9 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 121 sites in United States, Germany, Australia, Canada, France and 22 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 5 Dec 2016). 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?
Lead Complication-free Rate at 6 Months (time frame: Implant to 6 months post-implant). The study lists 2 primary outcomes in all. 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 5 Dec 2016.