APPROPRIATE - Rate Adaptive Pacing Sensor (APPROPRIATE)

Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer

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).

Study Overview

• Status: Terminated
• Conditions: Heart Diseases
• Intervention / Treatment: Device: Rate adaptive pacemaker; Device: Rate adaptive pacemaker

• Study Type: Interventional
• Enrollment (Actual): 566
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Jonesboro, Arkansas, United States
      • Cardiology Association of NE Arkansas
  • Iowa
    • Davenport, Iowa, United States
      • Genesis Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Accelerometer; Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.	Device: Rate adaptive pacemaker; Accelerometer sensor; Device: Rate adaptive pacemaker; Minute ventilation sensor
Active Comparator: Minute Ventilation; Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.	Device: Rate adaptive pacemaker; Accelerometer sensor; Device: Rate adaptive pacemaker; Minute ventilation sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Functional Capacity (Peak VO2).	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.	1 month and 2 months post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test	This outcome measure will be compared against baseline.	2 months post-implant
Metabolic Chronotropic Relationship (MCR) Slope		1 month and 2 months post-implant
Exercise Time		1 month and 2 months post-implant
VO2 at Ventilatory Threshold		1 month and 2 months post-implant

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Michael Giudici, MD, Genesis Heart Institute; Principal Investigator: F. Roosevelt Gilliam, MD, Cardiology Associates of NE Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2008
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: September 19, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pacemaker
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: CR-CA-082808-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No