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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00757666 |
The APPROPRIATE study will compare differences in functional capacity (peak VO2) between chronotropically incompetent patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or an accelerometer (motion-based).
Condition | Intervention | Phase |
---|---|---|
Heart Diseases |
Device: Rate adaptive pacemaker |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment |
Official Title: | Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer |
Estimated Enrollment: | 1000 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Accelerometer
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Device: Rate adaptive pacemaker
Accelerometer sensor
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2: Active Comparator
Minute ventilation
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Device: Rate adaptive pacemaker
Minute ventilation sensor
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pulmonary disease as defined by any one of the following:
Contact: Steven McQuillan | 651-582-2852 | steven.mcquillan@bsci.com |
United States, Texas | |
Memorial City Cardiology Associates | Recruiting |
Katy, Texas, United States, 77494 | |
Contact: Neil Schmitz 713-464-5035 nschmitz@mc-cardiology.com |
Principal Investigator: | Michael Giudici, MD | Genesis Heart Institute |
Principal Investigator: | F. Roosevelt Gilliam, MD | Cardiology Associates of NE Arkansas |
Responsible Party: | Boston Scientific CRM ( Director, Clinical Affairs ) |
Study ID Numbers: | CR-CA-082808-B |
Study First Received: | September 19, 2008 |
Last Updated: | June 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00757666 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pacemaker |
Heart Diseases |
Heart Diseases Cardiovascular Diseases |