Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response

PHASE4CompletedINTERVENTIONAL
Enrollment

1,491

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

February 29, 2008

Study Completion Date

December 31, 2010

Conditions
Bradycardia
Interventions
DEVICE

Closed Loop Stimulation (CLS)

Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the Closed Loop Stimulation (DDD-CLS or VVI-CLS) pacing mode for the long-term follow-up portion of this study.

DEVICE

Standard Rate Adaptive (R) Technology

Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the standard are adaptive pacing mode (DDDR or VVIR) for the long-term follow-up portion of this study.

DEVICE

Non-rate adaptive (DDD) pacing

Comparison of different pacing modes available on the Cylos pacemaker device. In this intervention group, subjects were programmed to the non-rate adaptive pacing mode (DDD or VVI) for the long-term follow-up portion of this study.

Trial Locations (99)

14569

Ohri Medical Group, P.C., Warsaw

18407

Lakshmi Mizin, M.D., Carbondale

18960

Alderfer & Travis Associates, Sellersville

19713

Alfieri Cardiology, Newark

23225

Cardiovascular Associates of Virginia, Richmond

23249

McGuire VA Medical Center, Richmond

28025

Heart Group of the Carolinas, Concord

28054

Carolina Heart Specialists, Gastonia

28602

Piedmont Cardiology, Hickory

28621

Carolina Heart Care, Elkin

29204

South Carolina Heart Center, Columbia

29403

Charleston Cardiology, Charleston

29505

Pee Dee Cardiology, Florence

29720

Carolina Heart Specialists, Lancaster

29732

Carolina Cardiology Associates, Rock Hill

29801

Carolina Heart and Vascular Center, Aiken

30342

Northside Cardiology, PC, Atlanta

30904

Doris Tummillo, MD, Augusta

31533

Collins Cardiology, Douglas

Douglas Medical Specialists, Douglas

32168

Complete Cardiology Care, New Smyrna Beach

32207

Southern Heart Group, Jacksonville

32504

Cardiology Consultants, PA, Pensacola

32901

Melbourne Internal Medicine Associates, Melbourne

32927

Space Coast Cardiology Consultants, Port Saint John

32955

Brevard Cardiovascular Research Association, Rockledge

35501

Richard Kim, MD, Jasper

35901

Cardiology Associates-Gadsden, Gadsden

North Alabama Cardiology Center, Gadsden

35951

Raymond Fernandez, Albertville

37923

Heart Rhythm Specialists of East Tennessee, Knoxville

38834

Pidikiti Cardiology, Corinth

39501

Coast Heart Institute, Gulfport

40215

Bluegrass Cardiology, Louisville

43623

Toledo Clinic Cardiology, Toledo

44106

University Hospitals Case Medical Center, Cleveland

44126

Westside Cardiology Associates, Inc., Fairview Park

48910

Thorasic and Cardiovascular Institute, Lansing

49525

West Michigan Cardiology, Grand Rapids

53188

Waukesha Heart Institute, Waukesha

55417

Minneapolis VA, Minneapolis

60637

University of Chicago Medical Center, Chicago

62002

St. Louis Cardiology Consultants - Alton, Alton

62801

Naeem Khan, MD, Centralia

62864

Amr El-Shafei, MD, Mount Vernon

63019

Cardiac Specialists of St. Lukes, Crystal City

63028

Manzoor Tariq, MD, Festus

63044

Midwest Health Professionals, P.C., Bridgeton

63122

Zia Ahmad, MD, FACC, St Louis

63128

Gateway Cardiology, PC, St Louis

63131

St. Louis Cardiology Center, P.C., St Louis

St. Louis Cardiovascular Center, St Louis

63136

Lalit Chouhan, MD, St Louis

St. Louis Heart and Vascular, P.C., St Louis

63640

Chand Medical Office, Farmington

64068

Liberty Cardiovascular Specialists, Liberty

65065

Lake Cardiovascular Institute, P.C., Osage Beach

65270

Heartland Medical Associates, LLC, Moberly

70112

Tulane University Medical Center, New Orleans

70121

Ochsner Clinic, New Orleans

74104

Oklahoma Heart Institute, Tulsa

74136

Bryan Lucenta, MD, Tulsa

75216

Dallas VA Medical Center, Dallas

76028

Fort Worth Heart, Burleson

76104

Fort Worth Heart, Fort Worth

76904

Cardiology Associates of West Texas, San Angelo

78229

Cardiac Electrophysiology Consultants of S. Texas, San Antonio

78705

Austin Cardiac Clinic, Austin

79106

Lone Star Arrhythmia and Heart Failure Center, Amarillo

79902

Cardiology Care Consultants, El Paso

80113

Western Cardiology Associates, Englewood

80210

Western Cardiology Associates, Denver

80218

Aurora Denver Cardiology Associates, Denver

80301

Colorado Cardiovascular Center, Boulder

80304

Boulder Medical Center, Boulder

84123

Wasatch Cardiology Consultants, PC, Salt Lake City

85006

Arizona Heart Institute, Phoenix

88011

White Sands Institute for Clinical Research, Las Cruces

90240

Caremore Medical Group, Downey

90241

Multani Medical Group, Downey

90503

Emad Khaleeli, MD, Torrance

90505

Torrance Memorial Medical Center, Torrance

90603

Alireza Jafari, MD, Whittier

90712

Kartik Thaker, MD, Lakewood

92562

St. Luke Cardiovascular Medical Group, Murrieta

92691

Mission Internal Medical Group, Mission Viejo

92804

N.R. Devaraj, M.D., Inc., Anaheim

93003

Ventura Cardiology, Ventura

93940

Cardio-Pulmonary Associates, Monterey

94510

Family Doctor Medical Group, Benicia

94533

Solano Cardiology, Fairfield

94538

Pacific Cardiology Associates, Fremont

95231

San Joaquin General Hospital, French Camp

95382

Cardiology Consultants, Turlock

95642

Kenny Charn, MD, Jackson

95825

Sacramento Heart & Vascular, Sacramento

98166

Daniel Gottlieb, Burien

02135

New England Cardiovascular Specialists, Boston

07052

Abbas Shehadeh, MD, FACC, West Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biotronik, Inc.

INDUSTRY