Clinical trial NCT00355797: Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
Official title: CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bradycardia
Keywords: Bradycardia
Sinus Node Dysfunction
Chronotropic incompetence
Pacemaker
Rate adaptive
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2006-07-25
Enrollment: 1491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)
timeFrame: within 45 days of enrollment
measure: Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)
timeFrame: within 45 days of enrollment
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: baseline and 12 months
measure: Mode Reprogramming
timeFrame: 12 months
measure: Atrial Fibrillation (AF) Burden
timeFrame: 12 months
measure: Cardiac Symptoms
timeFrame: 12 months
measure: Change in New York Heart Association (NYHA) Class
timeFrame: baseline and 12 months
measure: Change in 6-minute Walk Test Distance
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Albertville
country: United States
facility: Raymond Fernandez
state: Alabama
city: Gadsden
country: United States
facility: Cardiology Associates-Gadsden
state: Alabama
city: Gadsden
country: United States
facility: North Alabama Cardiology Center
state: Alabama
city: Jasper
country: United States
facility: Richard Kim, MD
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Institute
state: Arizona
city: Anaheim
country: United States
facility: N.R. Devaraj, M.D., Inc.
state: California
city: Benicia
country: United States
facility: Family Doctor Medical Group
state: California
city: Downey
country: United States
facility: Caremore Medical Group
state: California
city: Downey
country: United States
facility: Multani Medical Group
state: California
city: Fairfield
country: United States
facility: Solano Cardiology
state: California
city: Fremont
country: United States
facility: Pacific Cardiology Associates
state: California
city: French Camp
country: United States
facility: San Joaquin General Hospital
state: California
city: Jackson
country: United States
facility: Kenny Charn, MD
state: California
city: Lakewood
country: United States
facility: Kartik Thaker, MD
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Monterey
country: United States
facility: Cardio-Pulmonary Associates
state: California
city: Murrieta
country: United States
facility: St. Luke Cardiovascular Medical Group
state: California
city: Sacramento
country: United States
facility: Sacramento Heart & Vascular
state: California
city: Torrance
country: United States
facility: Emad Khaleeli, MD
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Turlock
country: United States
facility: Cardiology Consultants
state: California
city: Ventura
country: United States
facility: Ventura Cardiology
state: California
city: Whittier
country: United States
facility: Alireza Jafari, MD
state: California
city: Boulder
country: United States
facility: Colorado Cardiovascular Center
state: Colorado
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Denver
country: United States
facility: Western Cardiology Associates
state: Colorado
city: Denver
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Englewood
country: United States
facility: Western Cardiology Associates
state: Colorado
city: Newark
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Jacksonville
country: United States
facility: Southern Heart Group
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: New Smyrna Beach
country: United States
facility: Complete Cardiology Care
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants, PA
state: Florida
city: Port St. John
country: United States
facility: Space Coast Cardiology Consultants
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Research Association
state: Florida
city: Atlanta
country: United States
facility: Northside Cardiology, PC
state: Georgia
city: Augusta
country: United States
facility: Doris Tummillo, MD
state: Georgia
city: Douglas
country: United States
facility: Collins Cardiology
state: Georgia
city: Douglas
country: United States
facility: Douglas Medical Specialists
state: Georgia
city: Alton
country: United States
facility: St. Louis Cardiology Consultants - Alton
state: Illinois
city: Centralia
country: United States
facility: Naeem Khan, MD
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Mount Vernon
country: United States
facility: Amr El-Shafei, MD
state: Illinois
city: Louisville
country: United States
facility: Bluegrass Cardiology
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Boston
country: United States
facility: New England Cardiovascular Specialists
state: Massachusetts
city: Grand Rapids
country: United States
facility: West Michigan Cardiology
state: Michigan
city: Lansing
country: United States
facility: Thorasic and Cardiovascular Institute
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA
state: Minnesota
city: Corinth
country: United States
facility: Pidikiti Cardiology
state: Mississippi
city: Gulfport
country: United States
facility: Coast Heart Institute
state: Mississippi
city: Bridgeton
country: United States
facility: Midwest Health Professionals, P.C.
state: Missouri
city: Crystal City
country: United States
facility: Cardiac Specialists of St. Lukes
state: Missouri
city: Farmington
country: United States
facility: Chand Medical Office
state: Missouri
city: Festus
country: United States
facility: Manzoor Tariq, MD
state: Missouri
city: Liberty
country: United States
facility: Liberty Cardiovascular Specialists
state: Missouri
city: Moberly
country: United States
facility: Heartland Medical Associates, LLC
state: Missouri
city: Osage Beach
country: United States
facility: Lake Cardiovascular Institute, P.C.
state: Missouri
city: St. Louis
country: United States
facility: Zia Ahmad, MD, FACC
state: Missouri
city: St. Louis
country: United States
facility: Gateway Cardiology, PC
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Cardiology Center, P.C.
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Cardiovascular Center
state: Missouri
city: St. Louis
country: United States
facility: Lalit Chouhan, MD
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Heart and Vascular, P.C.
state: Missouri
city: West Orange
country: United States
facility: Abbas Shehadeh, MD, FACC
state: New Jersey
city: Las Cruces
country: United States
facility: White Sands Institute for Clinical Research
state: New Mexico
city: Warsaw
country: United States
facility: Ohri Medical Group, P.C.
state: New York
city: Concord
country: United States
facility: Heart Group of the Carolinas
state: North Carolina
city: Elkin
country: United States
facility: Carolina Heart Care
state: North Carolina
city: Gastonia
country: United States
facility: Carolina Heart Specialists
state: North Carolina
city: Hickory
country: United States
facility: Piedmont Cardiology
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Fairview Park
country: United States
facility: Westside Cardiology Associates, Inc.
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic Cardiology
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Bryan Lucenta, MD
state: Oklahoma
city: Carbondale
country: United States
facility: Lakshmi Mizin, M.D.
state: Pennsylvania
city: Sellersville
country: United States
facility: Alderfer & Travis Associates
state: Pennsylvania
city: Aiken
country: United States
facility: Carolina Heart and Vascular Center
state: South Carolina
city: Charleston
country: United States
facility: Charleston Cardiology
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Florence
country: United States
facility: Pee Dee Cardiology
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Cardiology Associates
state: South Carolina
city: Knoxville
country: United States
facility: Heart Rhythm Specialists of East Tennessee
state: Tennessee
city: Amarillo
country: United States
facility: Lone Star Arrhythmia and Heart Failure Center
state: Texas
city: Austin
country: United States
facility: Austin Cardiac Clinic
state: Texas
city: Burleson
country: United States
facility: Fort Worth Heart
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: El Paso
country: United States
facility: Cardiology Care Consultants
state: Texas
city: Fort Worth
country: United States
facility: Fort Worth Heart
state: Texas
city: San Angelo
country: United States
facility: Cardiology Associates of West Texas
state: Texas
city: San Antonio
country: United States
facility: Cardiac Electrophysiology Consultants of S. Texas
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Cardiology Consultants, PC
state: Utah
city: Richmond
country: United States
facility: Cardiovascular Associates of Virginia
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Burien
country: United States
facility: Daniel Gottlieb
state: Washington
city: Waukesha
country: United States
facility: Waukesha Heart Institute
state: Wisconsin
Study officials:
affiliation: Ochsner Health System
name: Freddy Abi-Samra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.