ProMRI Study of the Entovis Pacemaker System

CompletedOBSERVATIONAL
Enrollment

229

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

March 31, 2014

Study Completion Date

May 31, 2014

Conditions
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Interventions
DEVICE

Patients with a ProMRI Pacemaker System

Bradycardia Slow Heart Beat

OTHER

Magnetic Resonance Imaging (MRI) scan

MRI scan of head and lower back.

Trial Locations (25)

10016

New York

11355

New York Hospital Queens, Flushing

19047

Saint Mary Medical Center, Langhorne

20010

Washington Hospital Center, Washington D.C.

21502

Cumberland

23230

Richmond

27157

Winston-Salem

29601

Greenville

46306

Toledo Hospital, Toledo

46383

Valparaiso

48197

Saint Joseph Mercy Medical Center, Ypsilanti

52242

University of Iowa Hospitals and Clinics, Iowa City

63110

Washington University, St Louis

64132

Research Medical Center, Kansas City

70503

Louisiana Heart Rhythm Specialists, Lafayette

85251

Arizona Arrhythmia Consultants, Scottsdale

92270

Eisenhower Medical Center, Rancho Mirage

92663

Hoag Hospital, Newport Beach

94520

John Muir Medical Center, Concord

06510

Yale - New Haven Hospital, New Haven

02114

Massachusetts General Hospital, Boston

01805

Burlington

01655

University of Massachusetts Medical School, Worcester

08103

Camden

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik, Inc.

INDUSTRY