search
Back to results

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

Primary Purpose

Bradycardia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Closed Loop Stimulation (CLS)
Standard Rate Adaptive (R) Technology
Non-rate adaptive (DDD) pacing
Sponsored by
Biotronik, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bradycardia focused on measuring Bradycardia, Sinus Node Dysfunction, Chronotropic incompetence, Pacemaker, Rate adaptive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Raymond Fernandez
  • Cardiology Associates-Gadsden
  • North Alabama Cardiology Center
  • Richard Kim, MD
  • Arizona Heart Institute
  • N.R. Devaraj, M.D., Inc.
  • Family Doctor Medical Group
  • Caremore Medical Group
  • Multani Medical Group
  • Solano Cardiology
  • Pacific Cardiology Associates
  • San Joaquin General Hospital
  • Kenny Charn, MD
  • Kartik Thaker, MD
  • Mission Internal Medical Group
  • Cardio-Pulmonary Associates
  • St. Luke Cardiovascular Medical Group
  • Sacramento Heart & Vascular
  • Emad Khaleeli, MD
  • Torrance Memorial Medical Center
  • Cardiology Consultants
  • Ventura Cardiology
  • Alireza Jafari, MD
  • Colorado Cardiovascular Center
  • Boulder Medical Center
  • Western Cardiology Associates
  • Aurora Denver Cardiology Associates
  • Western Cardiology Associates
  • Alfieri Cardiology
  • Southern Heart Group
  • Melbourne Internal Medicine Associates
  • Complete Cardiology Care
  • Cardiology Consultants, PA
  • Space Coast Cardiology Consultants
  • Brevard Cardiovascular Research Association
  • Northside Cardiology, PC
  • Doris Tummillo, MD
  • Collins Cardiology
  • Douglas Medical Specialists
  • St. Louis Cardiology Consultants - Alton
  • Naeem Khan, MD
  • University of Chicago Medical Center
  • Amr El-Shafei, MD
  • Bluegrass Cardiology
  • Tulane University Medical Center
  • Ochsner Clinic
  • New England Cardiovascular Specialists
  • West Michigan Cardiology
  • Thorasic and Cardiovascular Institute
  • Minneapolis VA
  • Pidikiti Cardiology
  • Coast Heart Institute
  • Midwest Health Professionals, P.C.
  • Cardiac Specialists of St. Lukes
  • Chand Medical Office
  • Manzoor Tariq, MD
  • Liberty Cardiovascular Specialists
  • Heartland Medical Associates, LLC
  • Lake Cardiovascular Institute, P.C.
  • Zia Ahmad, MD, FACC
  • Gateway Cardiology, PC
  • St. Louis Cardiology Center, P.C.
  • St. Louis Cardiovascular Center
  • Lalit Chouhan, MD
  • St. Louis Heart and Vascular, P.C.
  • Abbas Shehadeh, MD, FACC
  • White Sands Institute for Clinical Research
  • Ohri Medical Group, P.C.
  • Heart Group of the Carolinas
  • Carolina Heart Care
  • Carolina Heart Specialists
  • Piedmont Cardiology
  • University Hospitals Case Medical Center
  • Westside Cardiology Associates, Inc.
  • Toledo Clinic Cardiology
  • Oklahoma Heart Institute
  • Bryan Lucenta, MD
  • Lakshmi Mizin, M.D.
  • Alderfer & Travis Associates
  • Carolina Heart and Vascular Center
  • Charleston Cardiology
  • South Carolina Heart Center
  • Pee Dee Cardiology
  • Carolina Heart Specialists
  • Carolina Cardiology Associates
  • Heart Rhythm Specialists of East Tennessee
  • Lone Star Arrhythmia and Heart Failure Center
  • Austin Cardiac Clinic
  • Fort Worth Heart
  • Dallas VA Medical Center
  • Cardiology Care Consultants
  • Fort Worth Heart
  • Cardiology Associates of West Texas
  • Cardiac Electrophysiology Consultants of S. Texas
  • Wasatch Cardiology Consultants, PC
  • Cardiovascular Associates of Virginia
  • McGuire VA Medical Center
  • Daniel Gottlieb
  • Waukesha Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Closed Loop Stimulation (CLS)

Standard Rate Adaptive Technology (R)

Non-rate adaptive pacing (DDD)

Arm Description

Pacemaker programmed with Closed Loop Stimulation rate adaptive technology for long-term follow-up data collection.

Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term follow-up data collection.

Pacemaker programmed with no rate adaption (DDD mode) for long-term follow-up data collection.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in Quality of Life
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
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
AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.
Cardiac Symptoms
Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.
Change in New York Heart Association (NYHA) Class
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
Change in number of 10 foot repetitions between baseline and 12-month visit were examined.

Full Information

First Posted
July 21, 2006
Last Updated
December 18, 2012
Sponsor
Biotronik, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00355797
Brief Title
Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response
Acronym
CLEAR
Official Title
CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
Bradycardia, Sinus Node Dysfunction, Chronotropic incompetence, Pacemaker, Rate adaptive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1491 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Closed Loop Stimulation (CLS)
Arm Type
Active Comparator
Arm Description
Pacemaker programmed with Closed Loop Stimulation rate adaptive technology for long-term follow-up data collection.
Arm Title
Standard Rate Adaptive Technology (R)
Arm Type
Active Comparator
Arm Description
Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term follow-up data collection.
Arm Title
Non-rate adaptive pacing (DDD)
Arm Type
Active Comparator
Arm Description
Pacemaker programmed with no rate adaption (DDD mode) for long-term follow-up data collection.
Intervention Type
Device
Intervention Name(s)
Closed Loop Stimulation (CLS)
Other Intervention Name(s)
Cylos Pacemaker
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Rate Adaptive (R) Technology
Other Intervention Name(s)
Cylos pacemaker
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non-rate adaptive (DDD) pacing
Other Intervention Name(s)
Cylos pacemaker
Intervention Description
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.
Primary Outcome Measure Information:
Title
Performance of Activities of Daily Living Tests (6-minute Walk and Sweep)
Description
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.
Time Frame
within 45 days of enrollment
Title
Pulse Pressure During Activities of Daily Living Tests (Orthostatic Test)
Description
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.
Time Frame
within 45 days of enrollment
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
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.
Time Frame
baseline and 12 months
Title
Mode Reprogramming
Description
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.
Time Frame
12 months
Title
Atrial Fibrillation (AF) Burden
Description
AF burden was measured at 12 months as the percentage of total atrial beats that are at or above 160 bpm.
Time Frame
12 months
Title
Cardiac Symptoms
Description
Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.
Time Frame
12 months
Title
Change in New York Heart Association (NYHA) Class
Description
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.
Time Frame
baseline and 12 months
Title
Change in 6-minute Walk Test Distance
Description
Change in number of 10 foot repetitions between baseline and 12-month visit were examined.
Time Frame
baseline and 12 months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
23419655
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs