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

Bradycardia Clinical Trial

— CLEAR  

Official title:

CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355797
• Other study ID #: 20060536
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2006
• Last updated: December 18, 2012
• Start date: May 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2012
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 1491
• Est. completion date: December 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Closed Loop Stimulation (CLS)
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.
• Standard Rate Adaptive (R) Technology
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.
• Non-rate adaptive (DDD) pacing
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	baseline and 12 months	No
Secondary	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.	12 months	No
Secondary	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.	12 months	No
Secondary	Cardiac Symptoms	Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.	12 months	No
Secondary	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.	baseline and 12 months	No
Secondary	Change in 6-minute Walk Test Distance	Change in number of 10 foot repetitions between baseline and 12-month visit were examined.	baseline and 12 months	No