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ArrhythmiaNCT01076374

MEDTRONIC ADAPTA, VERSA AND SENSIA nEw3 POST APPROVAL STUDY

An observational study of Arrhythmia and Bradycardia, run by Medtronic at 129 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. Read more about this study

Who is it for?
Any age
Conditions the study is for
Arrhythmia, Bradycardia
How many people
2,927 participants
Where
129 sitesin 12 countries
Study dates
Jul 2008to Dec 2015
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: Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG.

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 must also apply:
  • Subjects indicated for implant or within six months post-implant of a Medtronic market-released lead connected to a Medtronic Adapta®, Sensia™, or Versa™ IPG. The Medtronic lead must be used for pacing, sensing or defibrillation application.
  • Subjects who participated in a qualifying study (IDE) of a Medtronic cardiac therapy product and: 1) have a Medtronic Adapta®, Sensia™, or Versa™ IPG 2)product is market-released 3) complete implant and follow-up data, including product-related adverse events are available and 4) subject of appropriate legal guardian authorizes release of subject study data to SLS
  • Subjects implanted with a Medtronic Adapta®, Sensia™, or Versa™ IPG and Medtronic CapSure Epi Leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements.

Who cannot join

  • Subjects who are, or will be inaccessible for follow-up at a SLS center
  • Subjects with exclusion criteria required by local law (EMEA only)
  • Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant
  • Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Trial locations and contacts

129 sites in 12 countries.

129 sites in 12 countries

United States110 sites

  • Study site

    Akron, Ohio

  • Study site

    Albany, Georgia

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Louisiana

  • 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

    Bradenton, Florida

  • Study site

    Browns Mills, New Jersey

  • Study site

    Burlington, Vermont

  • Study site

    Charleston, South Carolina

  • 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, Missouri

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Coon Rapids, Minnesota

  • Study site

    Covington, Louisiana

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Downey, California

  • Study site

    Durham, North Carolina

  • Study site

    East Palo Alto, California

  • Study site

    Edgewood, Kentucky

  • Study site

    Erie, Pennsylvania

  • Study site

    Evansville, Indiana

  • Study site

    Fairfax, Virginia

  • Study site

    Fargo, North Dakota

  • Study site

    Florence, South Carolina

  • Study site

    Fort Worth, Texas

  • Study site

    Garden City, New York

  • Study site

    Germantown, Tennessee

  • Study site

    Gilbert, Arizona

  • Study site

    Greensboro, North Carolina

  • Study site

    Henderson, New York

  • Study site

    Houston, Texas

  • Study site

    Huntington, New York

  • Study site

    Indianapolis, Indiana

  • Study site

    Jacksonville, Florida

  • Study site

    Jonesboro, Arkansas

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    Kingsport, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lansing, Michigan

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lexington, Kentucky

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • 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

    Milwaukee, Wisconsin

  • Study site

    Minneapolis, Minnesota

  • Study site

    Nashville, Tennessee

  • Study site

    Newark, Delaware

  • Study site

    Oak Lawn, Illinois

  • Study site

    Ocean City, New Jersey

  • Study site

    Olympia, Washington

  • Study site

    Parlin, New Jersey

  • Study site

    Plano, Texas

  • Study site

    Portland, Oregon

  • Study site

    Poughkeepsie, New York

  • Study site

    Raleigh, North Carolina

  • Study site

    Redding, California

  • Study site

    Robbinsdale, Minnesota

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Saginaw, Michigan

  • Study site

    Saint Louis Park, Minnesota

  • Study site

    Saint Paul, Minnesota

  • Study site

    Salinas, California

  • Study site

    Salisbury, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Rosa, California

  • Study site

    Sayre, Pennsylvania

  • Study site

    Scottsdale, Arizona

  • Study site

    Silver Spring, Maryland

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Spokane, Washington

  • Study site

    Tacoma, Washington

  • Study site

    Takoma Park, Maryland

  • Study site

    Tampa, Florida

  • Study site

    The Woodlands, Texas

  • Study site

    Toledo, Ohio

  • Study site

    Torrance, California

  • Study site

    Towson, Maryland

  • Study site

    Utica, New York

  • Study site

    Van Nuys, California

  • Study site

    Washington, Missouri

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Orange, New Jersey

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Worcester, Massachusetts

  • Study site

    Ypsilanti, Michigan

Other trials in United States

Canada6 sites

  • Study site

    Calgary, Alberta

  • Study site

    Kingston, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Ottawa, Ontario

  • Study site

    Regina, Saskatchewan

  • Study site

    Toronto, Ontario

Other trials in Canada

France2 sites

  • Study site

    Marseille

  • Study site

    Nantes

Other trials in France

Italy2 sites

  • Study site

    Reggio Emilia

  • Study site

    Udine

Other trials in Italy

Netherlands2 sites

  • Study site

    Eindhoven

  • Study site

    Rotterdam

Other trials in Netherlands

Austria1 site

  • Study site

    Linz

Other trials in Austria

Belgium1 site

  • Study site

    Hasselt

Other trials in Belgium

Denmark1 site

  • Study site

    Copenhagen

Other trials in Denmark

Germany1 site

  • Study site

    Homburg/Saar

Other trials in Germany

Serbia1 site

  • Study site

    Belgrade

Other trials in Serbia

Sweden1 site

  • Study site

    Skövde

Other trials in Sweden

Switzerland1 site

  • Study site

    Zurich

Other trials in Switzerland

About this study

Official title: Medtronic Adapta/Versa/Sensia Long Term Reliability Study

The primary purpose of this study is to assess the long term reliability of the Medtronic Adapta®/Sensia™/Versa™ platform of devices. This study is required by FDA as a condition of approval of nEw3 devices. Patients will be followed for 5 years after implant. This study utilizes data collected from the System Longevity Study (SLS).

Read the detailed description

The rate of device malfunctions will be determined and a comparison to historical controls will be done.

Keywords
pacemaker
Medical subject headings
Arrhythmias, Cardiac, Bradycardia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of device malfunctions

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startJul 2008
  3. Primary completionOct 2015
  4. Study completionDec 2015

Resources

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
Prospective
Enrolment
2,927 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076374
Sponsor's protocol ID
nEw3 PAS
Status last verified
Apr 2018
First submitted
24 Feb 2010
Last updated
26 Apr 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmia and Bradycardia, run by Medtronic at 129 sites in 12 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 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Canada, France, Italy, Netherlands and 7 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?

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?

Rate of device malfunctions (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01076374.

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 26 Apr 2018.

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