APPROPRIATE - Rate Adaptive Pacing Sensor

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757666

Acronym

APPROPRIATE

Enrollment

566

Registered

2008-09-23

Start date

2008-12-31

Completion date

2011-01-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Pacemaker

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).

Interventions

DEVICERate adaptive pacemaker

Accelerometer sensor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Accelerometer Accelerometer	34
Minute Ventilation Minute ventilation	34
Total	68

Baseline characteristics

Characteristic	Minute Ventilation	Accelerometer	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	27 Participants	26 Participants	53 Participants
Age, Categorical Between 18 and 65 years	7 Participants	8 Participants	15 Participants
Age, Continuous	70.7 years STANDARD_DEVIATION 8.2	70.0 years STANDARD_DEVIATION 8.4	70.4 years STANDARD_DEVIATION 8.2
Region of Enrollment United States	34 participants	34 participants	68 participants
Sex: Female, Male Female	16 Participants	13 Participants	29 Participants
Sex: Female, Male Male	18 Participants	21 Participants	39 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 34	0 / 34
other Total, other adverse events	6 / 34	8 / 34
serious Total, serious adverse events	0 / 34	0 / 34

Outcome results

Primary

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.

Time frame: 1 month and 2 months post-implant