Skip Navigation

Advertise|Press|Contact|FAQ|CWConnect

Bookmark/Print/Share

Home » Clinical Trials » Arrhythmia

Clinical Trial Details

Overview

Research Study Summary

A clinical research study for the treatment of Arrhythmia or Bradycardia

Research Study Title

Medtronic Adapta/Versa/Sensia Long Term Reliability Study

Purpose

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 part of the Product Performance Platform (PPP).

To Learn more
Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Lead Sponsor

Medtronic Cardiac Rhythm Disease Management

Duration

32 Months

Facility Type

N/A

Eligibility

Both Male and Female ages up to N/A

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Site Locations (129)

Country State City Zip Facility and Contact
United States Alabama Birmingham Research Site
United States Alaska Anchorage Research Site
United States Arizona Gilbert Research Site
United States Arizona Scottsdale Research Site
United States Arkansas Jonesboro Research Site
United States Arkansas Little Rock Research Site
United States California Bakersville Research Site
United States California Chula Vista Research Site
United States California Downey Research Site
United States California East Palo Alto Research Site
United States California La Jolla Research Site
United States California Long Beach Research Site
United States California Los Angeles Research Site
United States California Redding Research Site
United States California Salinas Research Site
United States California San Diego Research Site
United States California Santa Rosa Research Site
United States California Torrance Research Site
United States California Van Nuys Research Site
United States Colorado Colorado Springs Research Site
United States Colorado Denver Research Site
United States Delaware Newark Research Site
United States District of Columbia Washington Research Site
United States Florida Bradenton Research Site
United States Florida Clearwater Research Site
United States Florida Jacksonville Research Site
United States Florida Melbourne Research Site
United States Florida Tampa Research Site
United States Georgia Albany Research Site
United States Georgia Atlanta Research Site
United States Georgia Columbus Research Site
United States Georgia Marietta Research Site
United States Illinois Oak Lawn Research Site
United States Indiana Evansville Research Site
United States Indiana Indianapolis Research Site
United States Iowa Des Moines Research Site
United States Kansas Kansas City Research Site
United States Kentucky Edgewood Research Site
United States Kentucky Lexington Research Site
United States Kentucky Louisville Research Site
United States Louisiana Alexandria Research Site
United States Louisiana Baton Rouge Research Site
United States Louisiana Covington Research Site
United States Maryland Salisbury Research Site
United States Maryland Silver Spring Research Site
United States Maryland Takoma Park Research Site
United States Maryland Towson Research Site
United States Massachusetts Worcester Research Site
United States Michigan Lansing Research Site
United States Michigan Marquette Research Site
United States Michigan Saginaw Research Site
United States Michigan Ypsilanti Research Site
United States Minnesota Coon Rapids Research Site
United States Minnesota Minneapolis Research Site
United States Minnesota Robbinsdale Research Site
United States Minnesota Rochester Research Site
United States Minnesota Saint Louis Park Research Site
United States Minnesota Saint Paul Research Site
United States Missouri Columbia Research Site
United States Missouri Kansas City Research Site
United States Missouri Washington Research Site
United States New Hampshire Lebanon Research Site
United States New Jersey Brown Mills Research Site
United States New Jersey Ocean Research Site
United States New Jersey Parlin Research Site
United States New Jersey West Orange Research Site
United States New Mexico Albuquerque Research Site
United States New York Garden City Research Site
United States New York Henderson Research Site
United States New York Huntington Research Site
United States New York Poughkeepsie Research Site
United States New York Rochester Research Site
United States New York Utica Research Site
United States North Carolina Durham Research Site
United States North Carolina Greensboro Research Site
United States North Carolina Raleigh Research Site
United States North Carolina Winston Salem Research Site
United States North Dakota Fargo Research Site
United States Ohio Akron Research Site
United States Ohio Cincinnati Research Site
United States Ohio Cleveland Research Site
United States Ohio Columbus Research Site
United States Ohio Toledo Research Site
United States Oregon Portland Research Site
United States Pennsylvania Erie Research Site
United States Pennsylvania Lancaster Research Site
United States Pennsylvania Sayre Research Site
United States South Carolina Charleston Research Site
United States South Carolina Columbia Research Site
United States South Carolina Florence Research Site
United States South Dakota Sioux Falls Research Site
United States Tennessee Chattanooga Research Site
United States Tennessee Germantown Research Site
United States Tennessee Kingsport Research Site
United States Tennessee Nashville Research Site
United States Texas Austin Research Site
United States Texas Dallas Research Site
United States Texas Fort Worth Research Site
United States Texas Houston Research Site
United States Texas Plano Research Site
United States Texas San Antonio Research Site
United States Texas The Woodlands Research Site
United States Vermont Burlington Research Site
United States Virginia Chesapeake Research Site
United States Virginia Fairfax Research Site
United States Washington Olympia Research Site
United States Washington Spokane Research Site
United States Washington Tacoma Research Site
United States Wisconsin Madison Research Site
United States Wisconsin Milwaukee Research Site
Austria Linz Research Site
Belgium Hasselt Research Site
Canada Alberta Calgary Research Site
Canada Ontario Kingston Research Site
Canada Ontario Ottawa Research Site
Canada Ontario Toronto Research Site
Canada Quebec Montreal Research Site
Canada Saskatchewan Regina Research Site
Denmark Copenhagen Research Site
France Marseille Research Site
France Nantes Research Site
Germany Homburg/Saar Research Site
Italy Reggio Emilia Research Site
Italy Udine Research Site
Netherlands Eindhoven Research Site
Netherlands Rotterdam Research Site
Serbia Belgrade Research Site
Sweden Skövde Research Site
Switzerland Zürich Research Site

Contact

nEw3 PAS Clinical Trial Leader

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

Name:
Address:
City:
State:
Zip/Postal Code:
Country:
Phone:
Email:  
Message:
 
Please leave this field empty.

NCT ID: NCT01076374

Date Last Changed: June 27, 2013

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.