Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
- Conditions
- Bradycardia
- Interventions
- Device: Closed Loop Stimulation (CLS)Device: Standard Rate Adaptive (R) TechnologyDevice: Non-rate adaptive (DDD) pacing
- Registration Number
- NCT00355797
- Lead Sponsor
- Biotronik, Inc.
- 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).
- Detailed Description
All patients enrolled in the CLEAR study are implanted with a Cylos pacemaker with Closed Loop Stimulation (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 Activities of Daily Living (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, CLS (DDD-CLS or VVI-CLS), standard rate response (DDDR or VVIR) and non-rate responsive mode (DDD or 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, CLS, R, or no-rate response 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, atrial fibrillation (AF) burden, cardiac symptoms, and New York Heart Association (NYHA) classification.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1491
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Closed Loop Stimulation (CLS) Closed Loop Stimulation (CLS) Pacemaker programmed with Closed Loop Stimulation rate adaptive technology for long-term follow-up data collection. Standard Rate Adaptive Technology (R) Standard Rate Adaptive (R) Technology Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term follow-up data collection. Non-rate adaptive pacing (DDD) Non-rate adaptive (DDD) pacing Pacemaker programmed with no rate adaption (DDD mode) for long-term follow-up data collection.
- Primary Outcome Measures
Name Time Method Performance of Activities of Daily Living Tests (6-minute Walk and Sweep) within 45 days of enrollment 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.
Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test) within 45 days of enrollment 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.
- Secondary Outcome Measures
Name Time Method Change in Quality of Life baseline and 12 months Change in Quality of life (QOL) score was determined from baseline to the 12 month follow-up visit. The QOL utilized the physical functioning scale of the SF-36 v2, in which a higher score indicates a better health perception. Best possible score was 57.03 while the worst possible score was 14.94.
Mode Reprogramming 12 months Number of subjects with device reprogramming from dual (atrial and ventricular pacing) to single chamber (ventricular pacing only) or from single (ventricular pacing only) to dual chamber (atrial and ventricular pacing) during the 12 month follow-up.
Atrial Fibrillation (AF) Burden 12 months AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.
Cardiac Symptoms 12 months Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.
Change in New York Heart Association (NYHA) Class baseline and 12 months Number of subjects with improved, no change, or worsened NYHA classification at the 12-month visit, as compared to baseline. NYHA classifications (I to IV) are used to assess the various stages of heart failure, with Class I relating to mild heart failure and Class IV relating to severe heart failure.
Change in 6-minute Walk Test Distance baseline and 12 months Change in number of 10 foot repetitions between baseline and 12-month visit were examined.
Trial Locations
- Locations (96)
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
New England Cardiovascular Specialists
🇺🇸Boston, Massachusetts, United States
Boulder Medical Center
🇺🇸Boulder, Colorado, United States
Western Cardiology Associates
🇺🇸Englewood, Colorado, United States
Bluegrass Cardiology
🇺🇸Louisville, Kentucky, United States
St. Louis Cardiology Consultants - Alton
🇺🇸Alton, Illinois, United States
Zia Ahmad, MD, FACC
🇺🇸St. Louis, Missouri, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Chand Medical Office
🇺🇸Farmington, Missouri, United States
Amr El-Shafei, MD
🇺🇸Mount Vernon, Illinois, United States
Melbourne Internal Medicine Associates
🇺🇸Melbourne, Florida, United States
Brevard Cardiovascular Research Association
🇺🇸Rockledge, Florida, United States
Southern Heart Group
🇺🇸Jacksonville, Florida, United States
Doris Tummillo, MD
🇺🇸Augusta, Georgia, United States
Alireza Jafari, MD
🇺🇸Whittier, California, United States
Naeem Khan, MD
🇺🇸Centralia, Illinois, United States
Space Coast Cardiology Consultants
🇺🇸Port St. John, Florida, United States
Complete Cardiology Care
🇺🇸New Smyrna Beach, Florida, United States
Cardiology Consultants, PA
🇺🇸Pensacola, Florida, United States
Northside Cardiology, PC
🇺🇸Atlanta, Georgia, United States
Collins Cardiology
🇺🇸Douglas, Georgia, United States
Douglas Medical Specialists
🇺🇸Douglas, Georgia, United States
Colorado Cardiovascular Center
🇺🇸Boulder, Colorado, United States
Arizona Heart Institute
🇺🇸Phoenix, Arizona, United States
Aurora Denver Cardiology Associates
🇺🇸Denver, Colorado, United States
Minneapolis VA
🇺🇸Minneapolis, Minnesota, United States
Cardiac Electrophysiology Consultants of S. Texas
🇺🇸San Antonio, Texas, United States
Wasatch Cardiology Consultants, PC
🇺🇸Salt Lake City, Utah, United States
Raymond Fernandez
🇺🇸Albertville, Alabama, United States
Cardiology Associates-Gadsden
🇺🇸Gadsden, Alabama, United States
North Alabama Cardiology Center
🇺🇸Gadsden, Alabama, United States
Richard Kim, MD
🇺🇸Jasper, Alabama, United States
Solano Cardiology
🇺🇸Fairfield, California, United States
Family Doctor Medical Group
🇺🇸Benicia, California, United States
N.R. Devaraj, M.D., Inc.
🇺🇸Anaheim, California, United States
Multani Medical Group
🇺🇸Downey, California, United States
Caremore Medical Group
🇺🇸Downey, California, United States
Pacific Cardiology Associates
🇺🇸Fremont, California, United States
Kenny Charn, MD
🇺🇸Jackson, California, United States
San Joaquin General Hospital
🇺🇸French Camp, California, United States
Kartik Thaker, MD
🇺🇸Lakewood, California, United States
Mission Internal Medical Group
🇺🇸Mission Viejo, California, United States
Cardio-Pulmonary Associates
🇺🇸Monterey, California, United States
St. Luke Cardiovascular Medical Group
🇺🇸Murrieta, California, United States
Emad Khaleeli, MD
🇺🇸Torrance, California, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Cardiology Consultants
🇺🇸Turlock, California, United States
Ventura Cardiology
🇺🇸Ventura, California, United States
West Michigan Cardiology
🇺🇸Grand Rapids, Michigan, United States
Alfieri Cardiology
🇺🇸Newark, Delaware, United States
Pidikiti Cardiology
🇺🇸Corinth, Mississippi, United States
Thorasic and Cardiovascular Institute
🇺🇸Lansing, Michigan, United States
Coast Heart Institute
🇺🇸Gulfport, Mississippi, United States
Gateway Cardiology, PC
🇺🇸St. Louis, Missouri, United States
Liberty Cardiovascular Specialists
🇺🇸Liberty, Missouri, United States
Midwest Health Professionals, P.C.
🇺🇸Bridgeton, Missouri, United States
Cardiac Specialists of St. Lukes
🇺🇸Crystal City, Missouri, United States
Manzoor Tariq, MD
🇺🇸Festus, Missouri, United States
Lake Cardiovascular Institute, P.C.
🇺🇸Osage Beach, Missouri, United States
Heartland Medical Associates, LLC
🇺🇸Moberly, Missouri, United States
White Sands Institute for Clinical Research
🇺🇸Las Cruces, New Mexico, United States
St. Louis Heart and Vascular, P.C.
🇺🇸St. Louis, Missouri, United States
Abbas Shehadeh, MD, FACC
🇺🇸West Orange, New Jersey, United States
St. Louis Cardiovascular Center
🇺🇸St. Louis, Missouri, United States
St. Louis Cardiology Center, P.C.
🇺🇸St. Louis, Missouri, United States
Heart Group of the Carolinas
🇺🇸Concord, North Carolina, United States
Ohri Medical Group, P.C.
🇺🇸Warsaw, New York, United States
Carolina Heart Care
🇺🇸Elkin, North Carolina, United States
Carolina Heart Specialists
🇺🇸Lancaster, South Carolina, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Piedmont Cardiology
🇺🇸Hickory, North Carolina, United States
Toledo Clinic Cardiology
🇺🇸Toledo, Ohio, United States
Westside Cardiology Associates, Inc.
🇺🇸Fairview Park, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Bryan Lucenta, MD
🇺🇸Tulsa, Oklahoma, United States
Lakshmi Mizin, M.D.
🇺🇸Carbondale, Pennsylvania, United States
Alderfer & Travis Associates
🇺🇸Sellersville, Pennsylvania, United States
Carolina Heart and Vascular Center
🇺🇸Aiken, South Carolina, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Pee Dee Cardiology
🇺🇸Florence, South Carolina, United States
Carolina Cardiology Associates
🇺🇸Rock Hill, South Carolina, United States
Heart Rhythm Specialists of East Tennessee
🇺🇸Knoxville, Tennessee, United States
Cardiology Care Consultants
🇺🇸El Paso, Texas, United States
Fort Worth Heart
🇺🇸Fort Worth, Texas, United States
Lone Star Arrhythmia and Heart Failure Center
🇺🇸Amarillo, Texas, United States
Cardiology Associates of West Texas
🇺🇸San Angelo, Texas, United States
Waukesha Heart Institute
🇺🇸Waukesha, Wisconsin, United States
Daniel Gottlieb
🇺🇸Burien, Washington, United States
Lalit Chouhan, MD
🇺🇸St. Louis, Missouri, United States
Sacramento Heart & Vascular
🇺🇸Sacramento, California, United States
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Cardiovascular Associates of Virginia
🇺🇸Richmond, Virginia, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Charleston Cardiology
🇺🇸Charleston, South Carolina, United States
Austin Cardiac Clinic
🇺🇸Austin, Texas, United States