Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
CLEAR
CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities
1 other identifier
interventional
1,491
1 country
99
Brief Summary
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 (R) and non-rate responsive mode (DDD) during activities of daily living (ADL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2006
Longer than P75 for phase_4
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 21, 2006
CompletedFirst Posted
Study publicly available on registry
July 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
June 27, 2011
CompletedDecember 20, 2012
December 1, 2012
1.8 years
July 21, 2006
June 6, 2011
December 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)
Six-minute walk test and sweep test results for subjects completing tests in all three pacing modes and requiring at least 80% pacing during both tests in the CLS and R pacing modes. The mean composite of repetitions (six minute walk plus sweep) are presented.
within 45 days of enrollment
Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)
Patients completing the orthostatic test in all three pacing modes and that had at least 80% pacing during the test in the CLS and R pacing modes are included in the analysis. The mean pulse pressure is provided.
within 45 days of enrollment
Secondary Outcomes (6)
Change in Quality of Life
baseline and 12 months
Mode Reprogramming
12 months
Atrial Fibrillation (AF) Burden
12 months
Cardiac Symptoms
12 months
Change in New York Heart Association (NYHA) Class
baseline and 12 months
- +1 more secondary outcomes
Study Arms (3)
Closed Loop Stimulation (CLS)
ACTIVE COMPARATORPacemaker programmed with Closed Loop Stimulation rate adaptive technology for long-term follow-up data collection.
Standard Rate Adaptive Technology (R)
ACTIVE COMPARATORPacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term follow-up data collection.
Non-rate adaptive pacing (DDD)
ACTIVE COMPARATORPacemaker programmed with no rate adaption (DDD mode) for long-term follow-up data collection.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Implanted within the last 45 days or being considered for implant with a BIOTRONIK pacemaker utilizing CLS rate adaptation technology (currently the Cylos family of pacemakers).
- Ability to give written informed consent
- Geographically stable and able to return for regular follow-ups for 12 months after ADL testing
- At least 18 years old
You may not qualify if:
- Patients physically limited and unable to perform all or parts of the ADL testing
- Currently enrolled in any other clinical study
- Patients with medical reasons that preclude regular participation in the follow-ups
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
Study Sites (99)
Raymond Fernandez
Albertville, Alabama, 35951, United States
Cardiology Associates-Gadsden
Gadsden, Alabama, 35901, United States
North Alabama Cardiology Center
Gadsden, Alabama, 35901, United States
Richard Kim, MD
Jasper, Alabama, 35501, United States
Arizona Heart Institute
Phoenix, Arizona, 85006, United States
N.R. Devaraj, M.D., Inc.
Anaheim, California, 92804, United States
Family Doctor Medical Group
Benicia, California, 94510, United States
Caremore Medical Group
Downey, California, 90240, United States
Multani Medical Group
Downey, California, 90241, United States
Solano Cardiology
Fairfield, California, 94533, United States
Pacific Cardiology Associates
Fremont, California, 94538, United States
San Joaquin General Hospital
French Camp, California, 95231, United States
Kenny Charn, MD
Jackson, California, 95642, United States
Kartik Thaker, MD
Lakewood, California, 90712, United States
Mission Internal Medical Group
Mission Viejo, California, 92691, United States
Cardio-Pulmonary Associates
Monterey, California, 93940, United States
St. Luke Cardiovascular Medical Group
Murrieta, California, 92562, United States
Sacramento Heart & Vascular
Sacramento, California, 95825, United States
Emad Khaleeli, MD
Torrance, California, 90503, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Cardiology Consultants
Turlock, California, 95382, United States
Ventura Cardiology
Ventura, California, 93003, United States
Alireza Jafari, MD
Whittier, California, 90603, United States
Colorado Cardiovascular Center
Boulder, Colorado, 80301, United States
Boulder Medical Center
Boulder, Colorado, 80304, United States
Western Cardiology Associates
Denver, Colorado, 80210, United States
Aurora Denver Cardiology Associates
Denver, Colorado, 80218, United States
Western Cardiology Associates
Englewood, Colorado, 80113, United States
Alfieri Cardiology
Newark, Delaware, 19713, United States
Southern Heart Group
Jacksonville, Florida, 32207, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901, United States
Complete Cardiology Care
New Smyrna Beach, Florida, 32168, United States
Cardiology Consultants, PA
Pensacola, Florida, 32504, United States
Space Coast Cardiology Consultants
Port Saint John, Florida, 32927, United States
Brevard Cardiovascular Research Association
Rockledge, Florida, 32955, United States
Northside Cardiology, PC
Atlanta, Georgia, 30342, United States
Doris Tummillo, MD
Augusta, Georgia, 30904, United States
Collins Cardiology
Douglas, Georgia, 31533, United States
Douglas Medical Specialists
Douglas, Georgia, 31533, United States
St. Louis Cardiology Consultants - Alton
Alton, Illinois, 62002, United States
Naeem Khan, MD
Centralia, Illinois, 62801, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Amr El-Shafei, MD
Mount Vernon, Illinois, 62864, United States
Bluegrass Cardiology
Louisville, Kentucky, 40215, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
New England Cardiovascular Specialists
Boston, Massachusetts, 02135, United States
West Michigan Cardiology
Grand Rapids, Michigan, 49525, United States
Thorasic and Cardiovascular Institute
Lansing, Michigan, 48910, United States
Minneapolis VA
Minneapolis, Minnesota, 55417, United States
Pidikiti Cardiology
Corinth, Mississippi, 38834, United States
Coast Heart Institute
Gulfport, Mississippi, 39501, United States
Midwest Health Professionals, P.C.
Bridgeton, Missouri, 63044, United States
Cardiac Specialists of St. Lukes
Crystal City, Missouri, 63019, United States
Chand Medical Office
Farmington, Missouri, 63640, United States
Manzoor Tariq, MD
Festus, Missouri, 63028, United States
Liberty Cardiovascular Specialists
Liberty, Missouri, 64068, United States
Heartland Medical Associates, LLC
Moberly, Missouri, 65270, United States
Lake Cardiovascular Institute, P.C.
Osage Beach, Missouri, 65065, United States
Zia Ahmad, MD, FACC
St Louis, Missouri, 63122, United States
Gateway Cardiology, PC
St Louis, Missouri, 63128, United States
St. Louis Cardiology Center, P.C.
St Louis, Missouri, 63131, United States
St. Louis Cardiovascular Center
St Louis, Missouri, 63131, United States
Lalit Chouhan, MD
St Louis, Missouri, 63136, United States
St. Louis Heart and Vascular, P.C.
St Louis, Missouri, 63136, United States
Abbas Shehadeh, MD, FACC
West Orange, New Jersey, 07052, United States
White Sands Institute for Clinical Research
Las Cruces, New Mexico, 88011, United States
Ohri Medical Group, P.C.
Warsaw, New York, 14569, United States
Heart Group of the Carolinas
Concord, North Carolina, 28025, United States
Carolina Heart Care
Elkin, North Carolina, 28621, United States
Carolina Heart Specialists
Gastonia, North Carolina, 28054, United States
Piedmont Cardiology
Hickory, North Carolina, 28602, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Westside Cardiology Associates, Inc.
Fairview Park, Ohio, 44126, United States
Toledo Clinic Cardiology
Toledo, Ohio, 43623, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104, United States
Bryan Lucenta, MD
Tulsa, Oklahoma, 74136, United States
Lakshmi Mizin, M.D.
Carbondale, Pennsylvania, 18407, United States
Alderfer & Travis Associates
Sellersville, Pennsylvania, 18960, United States
Carolina Heart and Vascular Center
Aiken, South Carolina, 29801, United States
Charleston Cardiology
Charleston, South Carolina, 29403, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
Pee Dee Cardiology
Florence, South Carolina, 29505, United States
Carolina Heart Specialists
Lancaster, South Carolina, 29720, United States
Carolina Cardiology Associates
Rock Hill, South Carolina, 29732, United States
Heart Rhythm Specialists of East Tennessee
Knoxville, Tennessee, 37923, United States
Lone Star Arrhythmia and Heart Failure Center
Amarillo, Texas, 79106, United States
Austin Cardiac Clinic
Austin, Texas, 78705, United States
Fort Worth Heart
Burleson, Texas, 76028, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Cardiology Care Consultants
El Paso, Texas, 79902, United States
Fort Worth Heart
Fort Worth, Texas, 76104, United States
Cardiology Associates of West Texas
San Angelo, Texas, 76904, United States
Cardiac Electrophysiology Consultants of S. Texas
San Antonio, Texas, 78229, United States
Wasatch Cardiology Consultants, PC
Salt Lake City, Utah, 84123, United States
Cardiovascular Associates of Virginia
Richmond, Virginia, 23225, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Daniel Gottlieb
Burien, Washington, 98166, United States
Waukesha Heart Institute
Waukesha, Wisconsin, 53188, United States
Related Publications (1)
Abi-Samra FM, Singh N, Rosin BL, Dwyer JV, Miller CD; CLEAR Study Investigators. Effect of rate-adaptive pacing on performance and physiological parameters during activities of daily living in the elderly: results from the CLEAR (Cylos Responds with Physiologic Rate Changes during Daily Activities) study. Europace. 2013 Jun;15(6):849-56. doi: 10.1093/europace/eus425. Epub 2013 Feb 17.
PMID: 23419655DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- CLEAR Study CSE
- Organization
- BIOTRONIK, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Freddy Abi-Samra, MD
Ochsner Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2006
First Posted
July 25, 2006
Study Start
May 1, 2006
Primary Completion
February 1, 2008
Study Completion
December 1, 2010
Last Updated
December 20, 2012
Results First Posted
June 27, 2011
Record last verified: 2012-12