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APPROPRIATE - Rate Adaptive Pacing Sensor
This study is currently recruiting participants.
Verified by Boston Scientific Corporation, January 2009
First Received: September 19, 2008   Last Updated: January 14, 2009   History of Changes
Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00757666
  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 Phase
Heart Diseases
Device: Rate adaptive pacemaker
Phase IV

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources
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

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Improvement in peak VO2. [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Metabolic chronotropic relationship (MCR) slope [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]
  • Exercise time [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]
  • VO2 at ventilatory threshold [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: October 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Accelerometer
Device: Rate adaptive pacemaker
Accelerometer sensor
2: Active Comparator
Minute ventilation
Device: Rate adaptive pacemaker
Minute ventilation sensor

  Eligibility

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

Inclusion Criteria:

  • Meets current pacemaker implantation indications
  • Likely to be chronotropically incompetent (i.e. unable to achieve appropriate heart rate during activity or does not have intrinsic atrial heart rates above 120 bpm, per physician judgment)
  • Willing and capable of providing informed consent for participation
  • Receiving a dual-chamber pacemaker
  • Plans to remain in the long-term care of his/her enrolling physician and is available for study follow-up for three months post-implant

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

Contacts
Contact: Steven McQuillan 651-582-2852 steven.mcquillan@bsci.com

Locations
United States, Texas
Memorial City Cardiology Associates Recruiting
Katy, Texas, United States, 77494
Contact: Neil Schmitz     713-464-5035     nschmitz@mc-cardiology.com    
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

No publications provided

Responsible Party: Boston Scientific CRM ( Director, Clinical Affairs )
Study ID Numbers: CR-CA-082808-B
Study First Received: September 19, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00757666     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Pacemaker

Study placed in the following topic categories:
Heart Diseases

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009