Model 4965 Post-Approval Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:19 - Any
Updated:3/1/2019
Start Date:September 1996
End Date:April 2011

Use our guide to learn which trials are right for you!

Medtronic Model 4965 Capsure Epi® Steroid-eluting Unipolar Epicardial Pacing Lead Post Approval Study

Safety and effectiveness will be summarized for the model 4965 lead. This study was conducted
within Medtronic's System Longevity Study (SLS).

As part of the requirement to satisfy the PMA Conditions of Approval for the Medtronic Model
4965 CapSure Epi® Steroid-Eluting Unipolar Epicardial Pacing Lead, 50 adult subjects who were
≥19 years old at time of implant were followed for one-year post-implant.

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 (A, B, or C) must also apply:

A. Subjects indicated for implant or within six months post-implant of a Medtronic
market-released lead connected to a market-released IPG, ICD, or CRT Device. The Medtronic
lead must be used for a pacing, sensing, or defibrillation application.

B. Subjects who participated in a qualifying study of a Medtronic cardiac therapy product
and for whom:

- product is market-released

- complete implant and follow-up data, including product-related adverse events, are
available

- subject or appropriate legal guardian authorizes release of subject study data to SLS
C. Subjects implanted with Medtronic CapSure Epi Leads (model 4965 and 4968) at a
minimum of three pre-selected sites to retrospectively collect data for post approval
requirements. Post approval requirements indicate 50 adult subjects implanted with a
model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. The
study plans to enroll approximately 100 subjects with a model 4965 lead and
approximately 200 subjects with a model 4968 lead.

Note: Subjects currently active in the Chronic Lead Study or Tachyarrhythmia Chronic
Systems Study will continue in the follow-up phase of the SLS.

Exclusion Criteria:

- Subjects receiving an implant of a Medtronic lead at a non-participating center and
the implant data and current status cannot be confirmed within 30 days after implant

- Subjects who are, or will be inaccessible for follow-up at a SLS center

- Subjects implanted with a Medtronic cardiac therapy device whose predetermined
enrollment limit for that specific product has been exceeded

- Subjects with exclusion criteria required by local law (EMEA only)
We found this trial at
85
sites
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Alexandria, LA
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Bakersfield, CA
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
8 Love Street
Bedford Park, South Australia 05042
?
mi
from
Bedford Park,
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Browns Mills, NJ
Click here to add this to my saved trials
?
mi
from
Burlington, VT
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Downey, CA
Click here to add this to my saved trials
?
mi
from
Doylestown, PA
Click here to add this to my saved trials
?
mi
from
East Palo Alto, CA
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Florence, SC
Click here to add this to my saved trials
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Marquette, MI
Click here to add this to my saved trials
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Mineola, NY
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Newburgh, IN
Click here to add this to my saved trials
?
mi
from
Oak Lawn, IL
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Ocean City, NJ
Click here to add this to my saved trials
?
mi
from
Olympia, WA
Click here to add this to my saved trials
?
mi
from
Parlin, NJ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Robbinsdale, MN
Click here to add this to my saved trials
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
?
mi
from
Salinas, CA
Click here to add this to my saved trials
?
mi
from
Salisbury, MD
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
Sayre, PA
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Silver Spring, MD
Click here to add this to my saved trials
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
?
mi
from
Southfield, MI
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
The Woodlands, TX
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Torrance, CA
Click here to add this to my saved trials
?
mi
from
Towson, MD
Click here to add this to my saved trials
?
mi
from
Van Nuys, CA
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Wellington, FL
Click here to add this to my saved trials
?
mi
from
West Orange, NJ
Click here to add this to my saved trials