APPROPRIATE - Rate Adaptive Pacing Sensor

Study Overview
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Brief Summary
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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).

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

Conditions
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Heart Diseases

Intervention / Treatment
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* Device: Rate adaptive pacemaker
* Device: Rate adaptive pacemaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pacemaker