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NCT00355797

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

Last Updated: 2012-12-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1491 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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

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Bradycardia

Keywords

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Bradycardia Sinus Node Dysfunction Chronotropic incompetence Pacemaker Rate adaptive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Closed Loop Stimulation (CLS)

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

Group Type ACTIVE_COMPARATOR

Closed Loop Stimulation (CLS)

Intervention Type DEVICE

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 Technology (R)

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

Group Type ACTIVE_COMPARATOR

Standard Rate Adaptive (R) Technology

Intervention Type DEVICE

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 pacing (DDD)

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

Group Type ACTIVE_COMPARATOR

Non-rate adaptive (DDD) pacing

Intervention Type DEVICE

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.

Interventions

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Closed Loop Stimulation (CLS)

Intervention Type DEVICE

Standard Rate Adaptive (R) Technology

Intervention Type DEVICE

Non-rate adaptive (DDD) pacing

Intervention Type DEVICE

Other Intervention Names

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Cylos Pacemaker Cylos pacemaker Cylos pacemaker

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Freddy Abi-Samra, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

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Raymond Fernandez

Albertville, Alabama, United States

Site Status

Cardiology Associates-Gadsden

Gadsden, Alabama, United States

Site Status

North Alabama Cardiology Center

Gadsden, Alabama, United States

Site Status

Richard Kim, MD

Jasper, Alabama, United States

Site Status

Arizona Heart Institute

Phoenix, Arizona, United States

Site Status

N.R. Devaraj, M.D., Inc.

Anaheim, California, United States

Site Status

Family Doctor Medical Group

Benicia, California, United States

Site Status

Caremore Medical Group

Downey, California, United States

Site Status

Multani Medical Group

Downey, California, United States

Site Status

Solano Cardiology

Fairfield, California, United States

Site Status

Pacific Cardiology Associates

Fremont, California, United States

Site Status

San Joaquin General Hospital

French Camp, California, United States

Site Status

Kenny Charn, MD

Jackson, California, United States

Site Status

Kartik Thaker, MD

Lakewood, California, United States

Site Status

Mission Internal Medical Group

Mission Viejo, California, United States

Site Status

Cardio-Pulmonary Associates

Monterey, California, United States

Site Status

St. Luke Cardiovascular Medical Group

Murrieta, California, United States

Site Status

Sacramento Heart & Vascular

Sacramento, California, United States

Site Status

Emad Khaleeli, MD

Torrance, California, United States

Site Status

Torrance Memorial Medical Center

Torrance, California, United States

Site Status

Cardiology Consultants

Turlock, California, United States

Site Status

Ventura Cardiology

Ventura, California, United States

Site Status

Alireza Jafari, MD

Whittier, California, United States

Site Status

Colorado Cardiovascular Center

Boulder, Colorado, United States

Site Status

Boulder Medical Center

Boulder, Colorado, United States

Site Status

Western Cardiology Associates

Denver, Colorado, United States

Site Status

Aurora Denver Cardiology Associates

Denver, Colorado, United States

Site Status

Western Cardiology Associates

Englewood, Colorado, United States

Site Status

Alfieri Cardiology

Newark, Delaware, United States

Site Status

Southern Heart Group

Jacksonville, Florida, United States

Site Status

Melbourne Internal Medicine Associates

Melbourne, Florida, United States

Site Status

Complete Cardiology Care

New Smyrna Beach, Florida, United States

Site Status

Cardiology Consultants, PA

Pensacola, Florida, United States

Site Status

Space Coast Cardiology Consultants

Port Saint John, Florida, United States

Site Status

Brevard Cardiovascular Research Association

Rockledge, Florida, United States

Site Status

Northside Cardiology, PC

Atlanta, Georgia, United States

Site Status

Doris Tummillo, MD

Augusta, Georgia, United States

Site Status

Collins Cardiology

Douglas, Georgia, United States

Site Status

Douglas Medical Specialists

Douglas, Georgia, United States

Site Status

St. Louis Cardiology Consultants - Alton

Alton, Illinois, United States

Site Status

Naeem Khan, MD

Centralia, Illinois, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Amr El-Shafei, MD

Mount Vernon, Illinois, United States

Site Status

Bluegrass Cardiology

Louisville, Kentucky, United States

Site Status

Tulane University Medical Center

New Orleans, Louisiana, United States

Site Status

Ochsner Clinic

New Orleans, Louisiana, United States

Site Status

New England Cardiovascular Specialists

Boston, Massachusetts, United States

Site Status

West Michigan Cardiology

Grand Rapids, Michigan, United States

Site Status

Thorasic and Cardiovascular Institute

Lansing, Michigan, United States

Site Status

Minneapolis VA

Minneapolis, Minnesota, United States

Site Status

Pidikiti Cardiology

Corinth, Mississippi, United States

Site Status

Coast Heart Institute

Gulfport, Mississippi, United States

Site Status

Midwest Health Professionals, P.C.

Bridgeton, Missouri, United States

Site Status

Cardiac Specialists of St. Lukes

Crystal City, Missouri, United States

Site Status

Chand Medical Office

Farmington, Missouri, United States

Site Status

Manzoor Tariq, MD

Festus, Missouri, United States

Site Status

Liberty Cardiovascular Specialists

Liberty, Missouri, United States

Site Status

Heartland Medical Associates, LLC

Moberly, Missouri, United States

Site Status