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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00146861 |
This study will compare how two different sensors inside the pacemaker may affect patients’ quality of life.
Condition | Intervention | Phase |
---|---|---|
Bradycardia |
Device: sensor programming |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind, Uncontrolled, Parallel Assignment |
Official Title: | Limiting Chronotropic Incompetence for Pacemaker Recipients |
Estimated Enrollment: | 1500 |
Study Start Date: | June 2003 |
The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared. A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR-CA-062703-B |
Study First Received: | September 2, 2005 |
Last Updated: | November 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00146861 |
Health Authority: | United States: Institutional Review Board |
Heart Diseases Bradycardia Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |