Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response - Full Text View

Sponsored by:	Biotronik, Inc.
Information provided by:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00355797

Purpose

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 and non-rate responsive modes during activities of daily living (ADL).

Condition	Intervention	Phase
Bradycardia	Device: Pacemaker	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Activities of daily living tests (6-minute walk, sweep, orthostatic) [ Time Frame: During ADL testing visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Mode reprogramming [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Atrial fibrillation (AF) burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cardiac symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
New York Heart Association (NYHA) class [ Time Frame: 12 months ] [ Designated as safety issue: No ]
6-minute walk test distance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2009
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pacemaker programmed with Closed Loop Stimulation rate adaptive technology	Device: Pacemaker Different types of programmed pacing modes in the pacemaker. The pacemaker has the ability to be programmed according to each of the study arms.
2: Active Comparator Pacemaker programmed with standard rate adaptive technology (accelerometer)	Device: Pacemaker Different types of programmed pacing modes in the pacemaker. The pacemaker has the ability to be programmed according to each of the study arms.
3: Active Comparator Pacemaker programmed with no rate adaption	Device: Pacemaker Different types of programmed pacing modes in the pacemaker. The pacemaker has the ability to be programmed according to each of the study arms.

Detailed Description:

All patients enrolled in the CLEAR study are implanted with a Cylos pacemaker with 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 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, DDD-CLS(VVI-CLS), DDDR(VVIR) and DDD(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, DDD-CLS (VVI-CLS), DDDR (VVIR), or DDD (VVI) 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, AF burden, cardiac symptoms, and NYHA classification.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355797

Contacts

Contact: Clay Cohorn, BS

(503) 387 2614

clay.cohorn@biotronik.com

Show 79 Study Locations

Sponsors and Collaborators

Biotronik, Inc.

Investigators

Principal Investigator:

Freddy Abi-Samra, MD

Ochsner Health System

More Information

Responsible Party:	Biotronik, Inc. ( Clay Cohorn, Clinical Studies Engineer II )
Study ID Numbers:	20060536
Study First Received:	July 21, 2006
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00355797
Health Authority:	United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:

Bradycardia
Sinus Node Dysfunction
Chronotropic incompetence
Pacemaker
Rate adaptive

Study placed in the following topic categories:

Heart Diseases
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009