The LEADLESS Pacemaker IDE Study (Leadless II)



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 2014
End Date:March 2020

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Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker

Prospective, non-randomized, single-arm, international multicenter, clinical safety and
effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR
pacemaker.

Following completion of enrollments in the IDE, patients will continue to be enrolled in the
continued access phase of the study under the same protocol.

The purpose of this study is to evaluate the safety and effectiveness of the leadless
pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The
Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in
battery and electrodes, for permanent implantation in the right ventricle. As a leadless
pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has
the same operating principles as a conventional pacemaker.

Inclusion Criteria:

1. Subject must have one of the clinical indications before device implant in adherence
with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:

- Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular
bundle branch block (BBB block), including slow ventricular rates (with or
without medication) associated with atrial fibrillation; or

- Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical
activity or short expected lifespan (but at least one year); or

- Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings;
and

2. Subject ≥18 years of age; and

3. Subject has life expectancy of at least one year; and

4. Subject is not enrolled in another clinical investigation; and

5. Subject is willing to comply with clinical investigation procedures and agrees to
return for all required follow-up visits, tests, and exams; and

6. Subject has been informed of the nature of the study, agrees to its provisions and has
provided written informed consent, approved by the IRB; and

7. Subject is not pregnant and does not plan to get pregnant during the course of the
study.

Exclusion Criteria:

1. Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in
arterial blood pressure with the onset of ventricular pacing; or

2. Subject is allergic or hypersensitive to <1 mg of dexamethasone sodium phosphate; or

3. Subject has a mechanical tricuspid valve prosthesis; or

4. Subject has a pre-existing endocardial pacing or defibrillation leads; or

5. Subject has current implantation of either conventional or subcutaneous implantable
cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or

6. Subject has an implanted vena cava filter; or

7. Subject has evidence of thrombosis in one of the veins used for access during the
procedure; or

8. Subject has an implanted leadless cardiac pacemaker; or

9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of
enrollment
We found this trial at
51
sites
Milwaukee, Wisconsin 14450
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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24 Sturtevant St
Orlando, Florida 32806
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Amarillo, Texas 79106
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Athens, Georgia 30606
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Birmingham, AL
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Burlington, Massachusetts 01805
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Chermside, Queensland 4032
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Detroit, Michigan 48236
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Edgewood, Kentucky 41017
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Fort Wayne, Indiana 46805
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Greensboro, North Carolina 27401
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Houston, Texas 77030
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Huntsville, Alabama 35801
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Kansas City, Kansas
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La Jolla, California 92037
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Lansing, Michigan 48910
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
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Littleton, Colorado 80120
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Los Angeles, California 90033
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Memphis, Tennessee 38104
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Mountain View, California 94040
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Murray, UT
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Naples, Florida 34102
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Neptune, New Jersey 07754
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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New York, New York 10029
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Newport Beach, California 92663
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Oklahoma City, Oklahoma
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Pasadena, California 91105
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Redwood City, California 94062
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Rochester, Minnesota 55905
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Rome, Georgia 30165
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Sacramento, California 95819
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Saint Louis, Missouri 63141
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San Antonio, Texas 78299
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Traverse, Michigan 49684
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York, Pennsylvania 17405
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Ypsilanti, Michigan 48197
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