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APPROPRIATE - Rate Adaptive Pacing Sensor (APPROPRIATE)

This study has been terminated.
(Difficulty enrollment; higher than planned patient attrition and data attrition)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00757666
First received: September 19, 2008
Last updated: May 17, 2017
Last verified: May 2017
  Purpose
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
Heart Diseases Device: Rate adaptive pacemaker

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Mean Change in Functional Capacity (Peak VO2). [ Time Frame: 1 month and 2 months post-implant ]

    The APPROPRIATE Study compared differences in functional capacity (peak VO2) between CI patients randomized to receive rate responsive pacing driven by either the minute ventilation (respiration-based) sensor or by an accelerometer (motion-based) sensor.

    The mean change in functional capactity will be compared against baseline; changes from baseline will be measured.



Secondary Outcome Measures:
  • Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test [ Time Frame: 2 months post-implant ]
    This outcome measure will be compared against baseline.

  • Metabolic Chronotropic Relationship (MCR) Slope [ Time Frame: 1 month and 2 months post-implant ]
  • Exercise Time [ Time Frame: 1 month and 2 months post-implant ]
  • VO2 at Ventilatory Threshold [ Time Frame: 1 month and 2 months post-implant ]

Enrollment: 566
Actual Study Start Date: December 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Accelerometer
Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.
Device: Rate adaptive pacemaker
Accelerometer sensor
Active Comparator: Minute Ventilation
Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.
Device: Rate adaptive pacemaker
Minute ventilation sensor

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets or met current pacemaker implantation indications
  • Willing and capable of providing informed consent for participation
  • Receiving a dual-chamber pacemaker or previously received a dual-chamber pacemaker with active atrial and ventricular leads
  • Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-enrollment

Exclusion Criteria:

  • Mobitz II second degree heart block
  • Third degree heart block
  • Chronic atrial fibrillation or uncontrolled atrial arrhythmias within the past 90 days prior to consent
  • Neuromuscular, orthopedic, or vascular disability that prevents normal walking or weight carrying (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
  • A symptom-limited exercise protocol is thought to be dangerous or contra-indicated, including but not limited to changing pattern of chest discomfort or uncontrolled arrhythmias
  • Pulmonary disease as defined by any one of the following:

    • Forced Vital Capacity (FVC) or Forced Expiratory Volume in one second (FEV1) < 60% of predicted values
    • Use of two or more pulmonary inhalers
    • Use of supplemental oxygen
    • Chronic use of oral steroids for pulmonary disease treatment
  • Life expectancy is less than 12 months due to other medical conditions, per physician discretion
  • Has or indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
  • Currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study.
  • Younger than 18 years of age
  • Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion)
  • Unable or unwilling to comply with the protocol requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757666

Locations
United States, Arkansas
Cardiology Association of NE Arkansas
Jonesboro, Arkansas, United States
United States, Iowa
Genesis Heart Institute
Davenport, Iowa, United States
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Michael Giudici, MD Genesis Heart Institute
Principal Investigator: F. Roosevelt Gilliam, MD Cardiology Associates of NE Arkansas
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00757666     History of Changes
Other Study ID Numbers: CR-CA-082808-B
Study First Received: September 19, 2008
Results First Received: January 24, 2012
Last Updated: May 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
Pacemaker

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2017