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| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of Pacemaker With Closed Loop Stimulation Compared to Pacemakers With and Without Standard Rate Response | ||||
| Official Title † | CLEAR: Cylos Pacemaker Responds With Physiologic Rate Changes During Daily Activities | ||||
| 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 and non-rate responsive modes during activities of daily living (ADL). |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Activities of daily living tests (6-minute walk, sweep, orthostatic) [ Time Frame: During ADL testing visit ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Bradycardia | ||||
| Intervention † | Device: Pacemaker | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 1500 | ||||
| Start Date † | May 2006 | ||||
| Completion Date | May 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00355797 | ||||
| Organization ID | 20060536 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Biotronik, Inc. | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Biotronik, Inc. | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | July 21, 2006 | ||||
| Last Updated Date | August 28, 2008 | ||||
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