Clinical trial NCT00757666: APPROPRIATE - Rate Adaptive Pacing Sensor
Official title: Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Diseases
Keywords: Pacemaker
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Functional Capacity (Peak VO2).
timeFrame: 1 month and 2 months post-implant
Secondary outcomes:
measure: Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test
timeFrame: 2 months post-implant
measure: Metabolic Chronotropic Relationship (MCR) Slope
timeFrame: 1 month and 2 months post-implant
measure: Exercise Time
timeFrame: 1 month and 2 months post-implant
measure: VO2 at Ventilatory Threshold
timeFrame: 1 month and 2 months post-implant
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Cardiology Association of NE Arkansas
state: Arkansas
city: Davenport
country: United States
facility: Genesis Heart Institute
state: Iowa
Study officials:
affiliation: Genesis Heart Institute
name: Michael Giudici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Associates of NE Arkansas
name: F. Roosevelt Gilliam, MD
role: PRINCIPAL_INVESTIGATOR
References: