Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

January 28, 2022 updated by: Medtronic

Attain Performa™ Left Ventricular Quadripolar Lead Post-Approval Study

Lead survivability will be summarized.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium
  • Canada
      • Calgary, Canada
      • Ottawa, Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • Ontario
      • London, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • La Rochelle, France
      • Nantes, France
  • Germany
      • Essen, Germany
      • Hannover, Germany
      • Ulm, Germany
  • Netherlands
      • Eindhoven, Netherlands
      • Maastricht, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
  • Switzerland
      • Zurich, Switzerland
  • United Kingdom
      • Liverpool, United Kingdom
      • Middlesbrough, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Chandler, Arizona, United States, 85226
      • Gilbert, Arizona, United States, 85295
    • Arkansas
      • Jonesboro, Arkansas, United States, 72410
    • California
      • Bakersfield, California, United States, 93301
      • Rancho Mirage, California, United States, 92270
      • Redwood City, California, United States, 94062
      • Salinas, California, United States, 93901
      • San Diego, California, United States, 92103
      • Stanford, California, United States, 94305
      • Torrance, California, United States, 90503
      • Van Nuys, California, United States, 91405
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Lakewood, Colorado, United States, 80228
    • Connecticut
      • New Haven, Connecticut, United States, 06519
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Bradenton, Florida, United States, 34205
      • Clearwater, Florida, United States, 33756
      • Jacksonville, Florida, United States, 32216
      • Safety Harbor, Florida, United States, 34695
    • Georgia
      • Albany, Georgia, United States, 31701
      • Marietta, Georgia, United States, 30060
    • Indiana
      • Evansville, Indiana, United States, 47710
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
      • Lexington, Kentucky, United States, 40503
      • Louisville, Kentucky, United States, 40207
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
    • Maryland
      • Hyattsville, Maryland, United States, 20782
      • Salisbury, Maryland, United States, 21804
      • Silver Spring, Maryland, United States, 20910
      • Takoma Park, Maryland, United States, 20912
    • Michigan
      • Lansing, Michigan, United States, 48912
      • Marquette, Michigan, United States, 49855
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
      • Robbinsdale, Minnesota, United States, 55422
      • Rochester, Minnesota, United States, 554905
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • Hattiesburg Clinic
    • Missouri
      • Columbia, Missouri, United States, 65201
      • Kansas City, Missouri, United States, 64111
      • Saint Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89169
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New Jersey
      • Morristown, New Jersey, United States, 07960
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Huntington, New York, United States, 11743
      • New York, New York, United States, 10032
      • Poughkeepsie, New York, United States, 12601
      • Utica, New York, United States, 13501
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
      • Durham, North Carolina, United States, 27705
      • Raleigh, North Carolina, United States, 27610
    • Ohio
      • Akron, Ohio, United States, 44304
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Toledo, Ohio, United States, 43608
    • Oregon
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
      • Bethlehem, Pennsylvania, United States
        • St Luke's University Health Network
      • Danville, Pennsylvania, United States, 17822
      • Erie, Pennsylvania, United States, 16550
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15213
      • Wilkes-Barre, Pennsylvania, United States, 18711
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
      • Dallas, Texas, United States, 75226
      • Fort Worth, Texas, United States, 76104
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75093
      • The Woodlands, Texas, United States, 77384
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Falls Church, Virginia, United States, 22042
      • Leesburg, Virginia, United States, 20176
    • Washington
      • Spokane, Washington, United States, 99204
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lead complication
Time Frame: 5 years

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.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Types of lead-related adverse device effects
Time Frame: 5 years
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.
5 years
Returned lead analysis
Time Frame: 5 years
A listing of analysis results of all Attain Performa study leads which are explanted and returned for analysis will be reported.
5 years
Lead survival estimate by model
Time Frame: 5 years
An analysis will be conducted at the end of the study to provide comparative statistics on the safety performance of each individual lead model.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Attain Performa™ PAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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