Safety and Efficacy of the Accent Magnetic Resonance Imaging™ (MRI) Pacemaker and Tendril MRI™ Lead

NACompletedINTERVENTIONAL
Enrollment

950

Participants

Timeline

Start Date

March 30, 2012

Primary Completion Date

February 2, 2018

Study Completion Date

February 2, 2018

Conditions
Adverse Effect of MRI on an Implanted Pacemaker LeadAdverse Effect of MRI on an Implanted Pacemaker
Interventions
DEVICE

Accent MRI system (lead safety)

Patients implanted with an Accent MRI system

DEVICE

Accent MRI system (with MRI scan)

Patients implanted with an Accent MRI system will receive an MRI scan

Trial Locations (70)

1200

Cliniques Universitaires Saint Luc, Brussels

5000

St. Andrews Hospital, Adelaide

14450

University of Rochester Medical Center, Rochester

Aurora Medical Group, Milwaukee

15212

Allegheny Singer Research Institute, Pittsburgh

17403

York Hospital, York

18840

Donald Guthrie Foundation for Education and Research, Sayre

20109

Virginia Cardiovascular Associates, PC, Manassas

22911

Martha Jefferson Hospital, Charlottesville

23507

Sentara Norfolk General Hospital, Norfolk

27615

Wake Forest University Medical Center Clinical Sciences, Winston-Salem

28204

Mid Carolina Cardiology, Charlotte

29401

Medical University of South Carolina, Charleston

29406

PMG Research of Charleston, LLC, Charleston

30041

Atlanta Heart Specialist, Atlanta

30606

Athens Cardiology Group, PC, Athens

32308

Tallahassee Research Institute, Tallahassee

32803

Florida Hospital Orlando, Orlando

32806

Orlando Health, Orlando

32955

Brevard Cardiovascular Research Associates, Rockledge

33462

Medical Specialists of the Palm Beaches, Atlantis

33606

University of South Florida, Cardiovascular Services, Tampa

33647

Watson Clinic Center, Lakeland

35233

University Hospital of Alabama at Birmingham, Birmingham

35801

Heart Center Research, Huntsville

40503

Central Baptist Hospital, Lexington

43210

The Ohio State University, Columbus

43213

Columbus Cardiovascular Associates, Columbus

44035

EMH Regional Medical Center, Elyria

44195

The Cleveland Clinic Foundation, Cleveland

44501

St. Elizabeth Health Center, Youngstown

48075

Providence Hospital, Southfield

48910

Thoracic Cardio Healthcare Foundation, Lansing

49503

Spectrum Health, Grand Rapids

55407

Minneapolis Heart Institute, Minneapolis

62701

Prairie Education and Research Cooperative, Springfield

63110

Washington University School of Medicine, St Louis

63131

Missouri Baptist Medical Center, St Louis

64111

St. Luke's Hospital, Kansas City

68124

Alegent Creighton Health, Omaha

70121

Ochsner Medical Center, New Orleans

70211

Kuopio University Hospital, Kuopio

72205

Baptist Health Medical Center, Little Rock

72211

Arkansas Heart Hospital, Little Rock

72758

Mercy Hospital Northwest Arkansas, Rogers

Abington Medical Specialists, Abington

73112

Integris Baptist Medical Center, Oklahoma City

Oklahoma Heart Institute at Utica, Tulsa

76508

Scott & White Memorial Hospital, Temple

78201

South Texas Cardiovascular Consultants, San Antonio

78756

Austin Heart, Austin

80012

Aurora Denver Cardiology Associates, Denver

80120

South Denver Cardiology Associates PC, Littleton

80538

Medical Center of the Rockies, Loveland

85016

Arizona Arrhythmia Research Center, Phoenix

91206

Glendale Adventist Medical Center, Glendale

91505

Raymond Schaerf, MD, Burbank

92037

Scripps Green Hospital, La Jolla

92270

Desert Cardiology Consultants, Rancho Mirage

92629

Premier Cardiology, Inc / Hoag Hospital, Newport Beach

92835

St. Jude Hospital, Fullerton

93308

Central Cardiology, Bakersfield

94520

John Muir Medical Center, Concord

95355

Memorial Medical Center, Modesto

95819

Mercy General Hospital, Sacramento

Sutter Memorial Hospital, Sacramento

98101

The Heart Institute at Virginia Mason, Seattle

98310

Kitsap Cardiology Consultants, Bremerton

27599-7075

University of North Carolina at Chapel Hill, Chapel Hill

3582 KE

Diakonessenhuis Utrecht, Utrecht

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY