Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response - Full Text View

Sponsor:	Biotronik, Inc.
Information provided by:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00355797

Purpose

This is a randomized, prospective, single-blinded, multi-center study involving approximately 1500 patients at 100 centers. The purpose of this study is to demonstrate the effectiveness of Closed Loop Stimulation (CLS) rate adaption technology over both standard rate responsive technology and non-rate responsive modes during activities of daily living (ADL).

Condition	Intervention	Phase
Bradycardia	Device: Pacemaker	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Activities of daily living tests (6-minute walk, sweep, orthostatic) [ Time Frame: During ADL testing visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mode reprogramming [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Atrial fibrillation (AF) burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cardiac symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
New York Heart Association (NYHA) class [ Time Frame: 12 months ] [ Designated as safety issue: No ]
6-minute walk test distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2010
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pacemaker programmed with Closed Loop Stimulation rate adaptive technology	Device: Pacemaker Different types of programmed pacing modes in the pacemaker. The pacemaker has the ability to be programmed according to each of the study arms.
2: Active Comparator Pacemaker programmed with standard rate adaptive technology (accelerometer)	Device: Pacemaker Different types of programmed pacing modes in the pacemaker. The pacemaker has the ability to be programmed according to each of the study arms.
3: Active Comparator Pacemaker programmed with no rate adaption	Device: Pacemaker Different types of programmed pacing modes in the pacemaker. The pacemaker has the ability to be programmed according to each of the study arms.

Detailed Description:

All patients enrolled in the CLEAR study are implanted with a Cylos pacemaker with CLS rate adaption technology. Any legally marketed pacing leads may be implanted with the Cylos family of pacemakers.

Prior to enrollment, patients provide written informed consent and are screened to ensure they are eligible to participate in the study. Patients enrolled in the study must have been implanted within 45 days prior to enrollment or are being considered for implant. Once enrolled and implanted with the Cylos pacemaker, the first 500 patients have 45 days to complete an ADL Testing visit. At the ADL Testing visit, each of the first 500 enrolled patients performs a 6-minute walk test, orthostatic test, and sweep test in three pacing modes, DDD-CLS(VVI-CLS), DDDR(VVIR) and DDD(VVI). The order of the pacing modes for testing is randomized in a 1:1:1 ratio. The study primarily analyzes the number of ADL repetitions performed during the 6-minute walk and sweep tests, pulse pressure during the orthostatic test, and secondarily analyzes heart rates during all three tests to compare CLS to both rate responsive and non-rate responsive pacing modes.

For all enrolled patients, the study collects additional data over a 12-month period. Patients are randomized and their pacemaker programmed to one of three pacing modes, DDD-CLS (VVI-CLS), DDDR (VVIR), or DDD (VVI) in a 2:1:1 ratio, respectively. The patients are then followed for a period of 12 months after the ADL testing (first 500 enrolled patients) or enrollment (patients 501 through 1500). The study collects the following secondary measures to compare CLS to both rate responsive and non-rate responsive pacing modes: changes in 6-minute walk test distance, quality of life, mode reprogramming, AF burden, cardiac symptoms, and NYHA classification.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355797

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Locations

United States, Alabama
Raymond Fernandez
Albertville, Alabama, United States, 35951
North Alabama Cardiology Center
Gadsden, Alabama, United States, 35901
Cardiology Associates-Gadsden
Gadsden, Alabama, United States, 35901
Richard Kim, MD
Jasper, Alabama, United States, 35501
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
United States, California
N.R. Devaraj, M.D., Inc.
Anaheim, California, United States, 92804
San Joaquin General Hospital
French Camp, California, United States, 95231
Caremore Medical Group
Downey, California, United States, 90240
Multani Medical Group
Downey, California, United States, 90241
Solano Cardiology
Fairfield, California, United States, 94533
Pacific Cardiology Associates
Fremont, California, United States, 94538
Family Doctor Medical Group
Benicia, California, United States, 94510
Kenny Charn, MD
Jackson, California, United States, 95642
Kartik Thaker, MD
Lakewood, California, United States, 90712
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
Cardio-Pulmonary Associates
Monterey, California, United States, 93940
Emad Khaleeli, MD
Torrance, California, United States, 90503
Sacramento Heart & Vascular
Sacramento, California, United States, 95825
St. Luke Cardiovascular Medical Group
Murrieta, California, United States, 92562
Torrance Memorial Medical Center
Torrance, California, United States, 90505
Cardiology Consultants
Turlock, California, United States, 95382
Ventura Cardiology
Ventura, California, United States, 93003
Alireza Jafari, MD
Whittier, California, United States, 90603
United States, Colorado
Colorado Cardiovascular Center
Boulder, Colorado, United States, 80301
Boulder Medical Center
Boulder, Colorado, United States, 80304
Western Cardiology Associates
Denver, Colorado, United States, 80210
Aurora Denver Cardiology Associates
Denver, Colorado, United States, 80218
Western Cardiology Associates
Englewood, Colorado, United States, 80113
United States, Delaware
Alfieri Cardiology
Newark, Delaware, United States, 19713
United States, Florida
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901
Southern Heart Group
Jacksonville, Florida, United States, 32207
Complete Cardiology Care
New Smyrna Beach, Florida, United States, 32168
Cardiology Consultants, PA
Pensacola, Florida, United States, 32504
Space Coast Cardiology Consultants
Port St. John, Florida, United States, 32927
Brevard Cardiovascular Research Association
Rockledge, Florida, United States, 32955
United States, Georgia
Northside Cardiology, PC
Atlanta, Georgia, United States, 30342
Doris Tummillo, MD
Augusta, Georgia, United States, 30904
Collins Cardiology
Douglas, Georgia, United States, 31533
Douglas Medical Specialists
Douglas, Georgia, United States, 31533
United States, Illinois
St. Louis Cardiology Consultants - Alton
Alton, Illinois, United States, 62002
Naeem Khan, MD
Centralia, Illinois, United States, 62801
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Amr El-Shafei, MD
Mount Vernon, Illinois, United States, 62864
United States, Kentucky
Bluegrass Cardiology
Louisville, Kentucky, United States, 40215
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
New England Cardiovascular Specialists
Boston, Massachusetts, United States, 02135
United States, Michigan
West Michigan Cardiology
Grand Rapids, Michigan, United States, 49525
Thorasic and Cardiovascular Institute
Lansing, Michigan, United States, 48910
United States, Minnesota
Minneapolis VA
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
Pidikiti Cardiology
Corinth, Mississippi, United States, 38834
Coast Heart Institute
Gulfport, Mississippi, United States, 39501
United States, Missouri
Midwest Health Professionals, P.C.
Bridgeton, Missouri, United States, 63044
Cardiac Specialists of St. Lukes
Crystal City, Missouri, United States, 63019
Chand Medical Office
Farmington, Missouri, United States, 63640
Manzoor Tariq, MD
Festus, Missouri, United States, 63028
Lalit Chouhan, MD
St. Louis, Missouri, United States, 63136
Heartland Medical Associates, LLC
Moberly, Missouri, United States, 65270
Lake Cardiovascular Institute, P.C.
Osage Beach, Missouri, United States, 65065
Gateway Cardiology, PC
St. Louis, Missouri, United States, 63128
St. Louis Cardiology Center, P.C.
St. Louis, Missouri, United States, 63131
Liberty Cardiovascular Specialists
Liberty, Missouri, United States, 64068
St. Louis Heart and Vascular, P.C.
St. Louis, Missouri, United States, 63136
St. Louis Cardiovascular Center
St. Louis, Missouri, United States, 63131
Zia Ahmad, MD, FACC
St. Louis, Missouri, United States, 63122
United States, New Jersey
Abbas Shehadeh, MD, FACC
West Orange, New Jersey, United States, 07052
United States, New Mexico
White Sands Institute for Clinical Research
Las Cruces, New Mexico, United States, 88011
United States, New York
Ohri Medical Group, P.C.
Warsaw, New York, United States, 14569
United States, North Carolina
Heart Group of the Carolinas
Concord, North Carolina, United States, 28025
Carolina Heart Care
Elkin, North Carolina, United States, 28621
Carolina Heart Specialists
Gastonia, North Carolina, United States, 28054
Piedmont Cardiology
Hickory, North Carolina, United States, 28602
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Westside Cardiology Associates, Inc.
Fairview Park, Ohio, United States, 44126
Toledo Clinic Cardiology
Toledo, Ohio, United States, 43623
United States, Oklahoma
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Bryan Lucenta, MD
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Lakshmi Mizin, M.D.
Carbondale, Pennsylvania, United States, 18407
Alderfer & Travis Associates
Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
Carolina Heart and Vascular Center
Aiken, South Carolina, United States, 29801
Charleston Cardiology
Charleston, South Carolina, United States, 29403
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
Pee Dee Cardiology
Florence, South Carolina, United States, 29505
Carolina Heart Specialists
Lancaster, South Carolina, United States, 29720
Carolina Cardiology Associates
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
Heart Rhythm Specialists of East Tennessee
Knoxville, Tennessee, United States, 37923
United States, Texas
Lone Star Arrhythmia and Heart Failure Center
Amarillo, Texas, United States, 79106
Austin Cardiac Clinic
Austin, Texas, United States, 78705
Fort Worth Heart
Burleson, Texas, United States, 76028
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Cardiology Care Consultants
El Paso, Texas, United States, 79902
Fort Worth Heart
Fort Worth, Texas, United States, 76104
Cardiology Associates of West Texas
San Angelo, Texas, United States, 76904
Cardiac Electrophysiology Consultants of S. Texas
San Antonio, Texas, United States, 78229
United States, Utah
Wasatch Cardiology Consultants, PC
Salt Lake City, Utah, United States, 84123
United States, Virginia
Cardiovascular Associates of Virginia
Richmond, Virginia, United States, 23225
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
Daniel Gottlieb
Burien, Washington, United States, 98166
United States, Wisconsin
Waukesha Heart Institute
Waukesha, Wisconsin, United States, 53188

Sponsors and Collaborators

Biotronik, Inc.

Investigators

Principal Investigator:

Freddy Abi-Samra, MD

Ochsner Health System

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Responsible Party:	Biotronik, Inc. ( Crystal Rink, Clinical Studies Engineer I )
Study ID Numbers:	20060536
Study First Received:	July 21, 2006
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00355797 History of Changes
Health Authority:	United States: Institutional Review Board