APPROPRIATE - Rate Adaptive Pacing Sensor

Not Applicable

Terminated

• Conditions: Heart Diseases
• Interventions: Device: Rate adaptive pacemaker

• Registration Number: NCT00757666
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-09-22
• Study First Posted: 2008-09-23
• Study Start: 2008-12
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-01-24
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-17
• Last Update Submitted: 2017-05-17
• Results First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 566

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerometer	Rate adaptive pacemaker	Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.
Minute Ventilation	Rate adaptive pacemaker	Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.

Primary Outcome Measures

Name	Time	Method
Mean Change in Functional Capacity (Peak VO2).	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

Name	Time	Method
Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test	2 months post-implant	This outcome measure will be compared against baseline.
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

Trial Locations

Locations (2)

Cardiology Association of NE Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

Genesis Heart Institute; 🇺🇸 Davenport, Iowa, United States