Phase
Condition
Dysrhythmia
Low Blood Pressure (Hypotension)
Heart Disease
Treatment
Aveir DR Leadless Pacemaker System
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject must have at least one of the clinical indications before device implant inadherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
Subject has a life expectancy of at least one year
Subject is willing to comply with clinical investigation procedures and agrees toreturn to clinic for all required follow-up visits, tests, and exams
Subject has been informed of the nature of the clinical investigation, agrees to itsprovisions and has provided a signed written informed consent, approved by theIRB/EC
Exclusion
Exclusion Criteria:
Subject is currently participating in another clinical investigation that mayconfound the results of this study as determined by the Sponsor
Subject is pregnant or nursing and those who plan pregnancy during the clinicalinvestigation follow-up period
Subject has presence of anatomic or comorbid conditions, or other medical, social,or psychological conditions that, in the investigator's opinion, could confound theassessment of the investigational device and/or implant procedure, limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements of the clinical investigation results
Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodiumphosphate or any blood or tissue contacting material listed in the IFU
Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
Subject has pre-existing, permanent endocardial pacing or defibrillation leads (doesnot include lead fragments)
Subject has current implantation of either conventional or subcutaneous implantablecardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricularleadless pacemaker)
Subject is implanted with an electrically-active implantable medical device withstimulation capabilities (such as neurological or cardiac stimulators)
Subject is unable to read or write
Study Design
Study Description
Connect with a study center
Kepler Universitätsklinikum GmbH
Linz, Upper Austria 4021
AustriaSite Not Available
UZ Gasthuisberg
Leuven, Flemish Brabant 3000
BelgiumSite Not Available
Foothills Medical Centre
Calgary, Alberta T2N 4N1
CanadaSite Not Available
HSC, Eastern Health
Saint John's, Newfoundland and Labrador A1B 3V6
CanadaSite Not Available
QE II Health Sciences
Halifax, Nova Scotia B3H 3A7
CanadaSite Not Available
Southlake Regional Health Centre
Newmarket, Ontario L3Y2P9
CanadaSite Not Available
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montréal, Quebec
CanadaSite Not Available
Nemocnice Na Homolce
Prague,
CzechiaSite Not Available
Hopital d'adulte de la Timone
Marseille, Alpes 13005
FranceSite Not Available
CHRU Albert Michallon
Grenoble, 38043
FranceSite Not Available
Kerckhoff-Klinik gGmbH
Bad Nauheim, 61231
GermanySite Not Available
Herzzentrum Leipzig GmbH
Leipzig, 04289
GermanySite Not Available
Prince of Wales Hospital
Hong Kong, Hk Sar
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong, HK SAR
Hong KongSite Not Available
Centro Cardiologico Monzino
Milano, 20138
ItalySite Not Available
Azienda Ospedaliero Universitaria Pisana
Pisa, 56100
ItalySite Not Available
Kokura Memorial Hospital
Kitakyushu, Fukuoka
JapanSite Not Available
Kurashiki Central Hospital
Kurashiki-shi, Okayama
JapanSite Not Available
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka
JapanSite Not Available
Tokyo Women's Medical University
Tokyo,
JapanSite Not Available
Amsterdam Academic Medical Centre (AMC)
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Hospital Universitario de Badajoz
Badajoz, Extmdra 06080
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
John Radcliffe Hospital
Oxford, Soeast OX3 9DU
United KingdomSite Not Available
Royal Brompton Hospital
London, SW3 6NP
United KingdomSite Not Available
Cardiology Associates of Mobile, Inc.
Mobile, Alabama 36608
United StatesSite Not Available
HonorHealth
Scottsdale, Arizona 85258
United StatesSite Not Available
Arrhythmia Research Group
Jonesboro, Arkansas 72401
United StatesSite Not Available
Arkansas Heart Hospital
Little Rock, Arkansas 72211
United StatesSite Not Available
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United StatesSite Not Available
USC University Hospital
Los Angeles, California 90033
United StatesSite Not Available
Premier Cardiology, Inc
Newport Beach, California 92663
United StatesSite Not Available
Providence Medical Foundation
Orange, California 92868
United StatesSite Not Available
Huntington Memorial Hospital
Pasadena, California 91105
United StatesSite Not Available
University of California at San Diego (UCSD) Medical Center
San Diego, California 92118-8411
United StatesSite Not Available
Pacific Heart Institute
Santa Monica, California 90404
United StatesSite Not Available
South Denver Cardiology Associates PC
Littleton, Colorado 80120
United StatesSite Not Available
Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Baptist Medical Center
Jacksonville, Florida 32207
United StatesSite Not Available
Naples Heart Rhythm Specialists, PA
Naples, Florida 34119
United StatesSite Not Available
AdventHealth Orlando
Orlando, Florida 32803
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Prairie Education & Research Cooperative
Springfield, Illinois 62769
United StatesSite Not Available
Iowa Heart Center
West Des Moines, Iowa 50266
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas 66211
United StatesSite Not Available
Baptist Health Lexington
Lexington, Kentucky 40503
United StatesSite Not Available
Ochsner Medical Center
New Orleans, Louisiana 70121
United StatesSite Not Available
Charlton Memorial Hospital
Fall River, Massachusetts 02720
United StatesSite Not Available
Sparrow Clinical Research Institute
Lansing, Michigan 48912
United StatesSite Not Available
Providence Hospital
Southfield, Michigan 48075
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Bryan Heart
Lincoln, Nebraska 68506
United StatesSite Not Available
Catholic Medical Center
Manchester, New Hampshire 03102
United StatesSite Not Available
Jersey Shore University Medical Center
Ocean City, New Jersey 07712
United StatesSite Not Available
North Shore University Hospital
Manhasset, New York 11030
United StatesSite Not Available
Mount Sinai Hospital
New York, New York 10029
United StatesSite Not Available
New York Presbyterian Hospital/Cornell University
New York, New York 10021
United StatesSite Not Available
New York University Hospital
New York, New York 10016
United StatesSite Not Available
New York-Presbyterian/Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Cardiac Arrhythmia & Pacemaker Center
Roslyn, New York 11576
United StatesSite Not Available
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Ohio Health Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
Hightower Clinical
Oklahoma City, Oklahoma 73102
United StatesSite Not Available
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma 73135
United StatesSite Not Available
Providence St. Vincent Medical Center
Portland, Oregon 97225
United StatesSite Not Available
Lancaster General Hospital
Lancaster, Pennsylvania 17602
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Donald Guthrie Foundation for Education & Research
Sayre, Pennsylvania 18840
United StatesSite Not Available
Pinnacle Health System
Wormleysburg, Pennsylvania 17043
United StatesSite Not Available
Sanford USD Medical Center
Sioux Falls, South Dakota 57104
United StatesSite Not Available
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
United StatesSite Not Available
Texas Cardiac Arrhythmia
Austin, Texas 78705
United StatesSite Not Available
The Methodist Hospital
Houston, Texas 77030
United StatesSite Not Available
South Texas Cardiovascular Consultants
San Antonio, Texas 78201
United StatesSite Not Available
Memorial Hermann Hospital
The Woodlands, Texas 77380
United StatesSite Not Available
University of Utah Hospital
Salt Lake City, Utah 84132
United StatesSite Not Available
Franciscan Heart & Vascular Associates
Tacoma, Washington 98405
United StatesSite Not Available
Aurora Medical Group
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Aspirus Wausau Hospital
Wausau, Wisconsin 54401
United StatesSite Not Available

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