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BradycardiaPhase 4CLEARNCT00355797

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

A Phase 4 study testing Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology and Non-rate adaptive (DDD) pacing in people with Bradycardia, run by Biotronik, Inc. at 99 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bradycardia
What is being tested?
Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology and Non-rate adaptive (DDD) pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,491 participants
Where
99 sitesUnited States
Study dates
May 2006to Dec 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

99 sites in 1 country.

99 sites in 1 country

United States99 sites

  • Carolina Heart and Vascular Center

    Aiken, South Carolina, 29801

  • Raymond Fernandez

    Albertville, Alabama, 35951

  • St. Louis Cardiology Consultants - Alton

    Alton, Illinois, 62002

  • Lone Star Arrhythmia and Heart Failure Center

    Amarillo, Texas, 79106

  • N.R. Devaraj, M.D., Inc.

    Anaheim, California, 92804

  • Northside Cardiology, PC

    Atlanta, Georgia, 30342

  • Doris Tummillo, MD

    Augusta, Georgia, 30904

  • Austin Cardiac Clinic

    Austin, Texas, 78705

  • Family Doctor Medical Group

    Benicia, California, 94510

  • New England Cardiovascular Specialists

    Boston, Massachusetts, 02135

  • Colorado Cardiovascular Center

    Boulder, Colorado, 80301

  • Boulder Medical Center

    Boulder, Colorado, 80304

  • Midwest Health Professionals, P.C.

    Bridgeton, Missouri, 63044

  • Daniel Gottlieb

    Burien, Washington, 98166

  • Fort Worth Heart

    Burleson, Texas, 76028

  • Lakshmi Mizin, M.D.

    Carbondale, Pennsylvania, 18407

  • Naeem Khan, MD

    Centralia, Illinois, 62801

  • Charleston Cardiology

    Charleston, South Carolina, 29403

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • Heart Group of the Carolinas

    Concord, North Carolina, 28025

  • Pidikiti Cardiology

    Corinth, Mississippi, 38834

  • Cardiac Specialists of St. Lukes

    Crystal City, Missouri, 63019

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Western Cardiology Associates

    Denver, Colorado, 80210

  • Aurora Denver Cardiology Associates

    Denver, Colorado, 80218

  • Collins Cardiology

    Douglas, Georgia, 31533

  • Douglas Medical Specialists

    Douglas, Georgia, 31533

  • Caremore Medical Group

    Downey, California, 90240

  • Multani Medical Group

    Downey, California, 90241

  • Cardiology Care Consultants

    El Paso, Texas, 79902

  • Carolina Heart Care

    Elkin, North Carolina, 28621

  • Western Cardiology Associates

    Englewood, Colorado, 80113

  • Solano Cardiology

    Fairfield, California, 94533

  • Westside Cardiology Associates, Inc.

    Fairview Park, Ohio, 44126

  • Chand Medical Office

    Farmington, Missouri, 63640

  • Manzoor Tariq, MD

    Festus, Missouri, 63028

  • Pee Dee Cardiology

    Florence, South Carolina, 29505

  • Fort Worth Heart

    Fort Worth, Texas, 76104

  • Pacific Cardiology Associates

    Fremont, California, 94538

  • San Joaquin General Hospital

    French Camp, California, 95231

  • Cardiology Associates-Gadsden

    Gadsden, Alabama, 35901

  • North Alabama Cardiology Center

    Gadsden, Alabama, 35901

  • Carolina Heart Specialists

    Gastonia, North Carolina, 28054

  • West Michigan Cardiology

    Grand Rapids, Michigan, 49525

  • Coast Heart Institute

    Gulfport, Mississippi, 39501

  • Piedmont Cardiology

    Hickory, North Carolina, 28602

  • Kenny Charn, MD

    Jackson, California, 95642

  • Southern Heart Group

    Jacksonville, Florida, 32207

  • Richard Kim, MD

    Jasper, Alabama, 35501

  • Heart Rhythm Specialists of East Tennessee

    Knoxville, Tennessee, 37923

  • Kartik Thaker, MD

    Lakewood, California, 90712

  • Carolina Heart Specialists

    Lancaster, South Carolina, 29720

  • Thorasic and Cardiovascular Institute

    Lansing, Michigan, 48910

  • White Sands Institute for Clinical Research

    Las Cruces, New Mexico, 88011

  • Liberty Cardiovascular Specialists

    Liberty, Missouri, 64068

  • Bluegrass Cardiology

    Louisville, Kentucky, 40215

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Minneapolis VA

    Minneapolis, Minnesota, 55417

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • Heartland Medical Associates, LLC

    Moberly, Missouri, 65270

  • Cardio-Pulmonary Associates

    Monterey, California, 93940

  • Amr El-Shafei, MD

    Mount Vernon, Illinois, 62864

  • St. Luke Cardiovascular Medical Group

    Murrieta, California, 92562

  • Tulane University Medical Center

    New Orleans, Louisiana, 70112

  • Ochsner Clinic

    New Orleans, Louisiana, 70121

  • Complete Cardiology Care

    New Smyrna Beach, Florida, 32168

  • Alfieri Cardiology

    Newark, Delaware, 19713

  • Lake Cardiovascular Institute, P.C.

    Osage Beach, Missouri, 65065

  • Cardiology Consultants, PA

    Pensacola, Florida, 32504

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

  • Space Coast Cardiology Consultants

    Port Saint John, Florida, 32927

  • Cardiovascular Associates of Virginia

    Richmond, Virginia, 23225

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Carolina Cardiology Associates

    Rock Hill, South Carolina, 29732

  • Brevard Cardiovascular Research Association

    Rockledge, Florida, 32955

  • Sacramento Heart & Vascular

    Sacramento, California, 95825

  • Wasatch Cardiology Consultants, PC

    Salt Lake City, Utah, 84123

  • Cardiology Associates of West Texas

    San Angelo, Texas, 76904

  • Cardiac Electrophysiology Consultants of S. Texas

    San Antonio, Texas, 78229

  • Alderfer & Travis Associates

    Sellersville, Pennsylvania, 18960

  • Zia Ahmad, MD, FACC

    St Louis, Missouri, 63122

  • Gateway Cardiology, PC

    St Louis, Missouri, 63128

  • St. Louis Cardiology Center, P.C.

    St Louis, Missouri, 63131

  • St. Louis Cardiovascular Center

    St Louis, Missouri, 63131

  • Lalit Chouhan, MD

    St Louis, Missouri, 63136

  • St. Louis Heart and Vascular, P.C.

    St Louis, Missouri, 63136

  • Toledo Clinic Cardiology

    Toledo, Ohio, 43623

  • Emad Khaleeli, MD

    Torrance, California, 90503

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Bryan Lucenta, MD

    Tulsa, Oklahoma, 74136

  • Cardiology Consultants

    Turlock, California, 95382

  • Ventura Cardiology

    Ventura, California, 93003

  • Ohri Medical Group, P.C.

    Warsaw, New York, 14569

  • Waukesha Heart Institute

    Waukesha, Wisconsin, 53188

  • Abbas Shehadeh, MD, FACC

    West Orange, New Jersey, 07052

  • Alireza Jafari, MD

    Whittier, California, 90603

Other trials in United States

About this study

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

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).

Read the 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.

Conditions
Bradycardia
Being tested
Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology, Non-rate adaptive (DDD) pacing
Keywords
Bradycardia, Sinus Node Dysfunction, Chronotropic incompetence, Pacemaker, Rate adaptive
Medical subject headings
Bradycardia, Sick Sinus Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed Loop Stimulation (CLS)Device

    Also called Cylos Pacemaker

    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) TechnologyDevice

    Also called Cylos pacemaker

    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) pacingDevice

    Also called Cylos pacemaker

    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.

Study groups in NCT00355797
Study groupRoleWhat they receive
Closed Loop Stimulation (CLS)Active comparatorPacemaker programmed with Closed Loop Stimulation rate adaptive technology for long-term follow-up data collection.
Receives: Device: Closed Loop Stimulation (CLS)
Standard Rate Adaptive Technology (R)Active comparatorPacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term follow-up data collection.
Receives: Device: Standard Rate Adaptive (R) Technology
Non-rate adaptive pacing (DDD)Active comparatorPacemaker programmed with no rate adaption (DDD mode) for long-term follow-up data collection.
Receives: Device: Non-rate adaptive (DDD) pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 45 days of enrollment

  2. 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.

    Measured: within 45 days of enrollment

Secondary outcomes (6)

  1. 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.

    Measured: baseline and 12 months

  2. 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.

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. Cardiac Symptoms

    Number of subjects exhibiting each cardiac symptom was determined at the 12 month follow-up visit.

    Measured: 12 months

  5. 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.

    Measured: baseline and 12 months

  6. Change in 6-minute Walk Test Distance

    Change in number of 10 foot repetitions between baseline and 12-month visit were examined.

    Measured: baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionFeb 2008
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,491 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00355797
Sponsor's protocol ID
20060536
Acronym
CLEAR
Status last verified
Dec 2012
First submitted
21 Jul 2006
Last updated
20 Dec 2012
Data monitoring committee
No

Publications

  • 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.

    PubMed 23419655

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Closed Loop Stimulation (CLS), Standard Rate Adaptive (R) Technology and Non-rate adaptive (DDD) pacing in people with Bradycardia, run by Biotronik, Inc. at 99 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of Activities of Daily Living Tests (6-minute Walk and Sweep) (time frame: within 45 days of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00355797, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.

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CLEAR Clinical Trial NCT00355797 | AzTrials