Study Stopped
Difficulty enrollment; higher than planned patient attrition and data attrition
APPROPRIATE - Rate Adaptive Pacing Sensor
APPROPRIATE
Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer
1 other identifier
interventional
566
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2008
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
June 14, 2017
CompletedJune 14, 2017
May 1, 2017
2.1 years
September 19, 2008
January 24, 2012
May 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test
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
Study Arms (2)
Accelerometer
ACTIVE COMPARATORPatients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor.
Minute Ventilation
ACTIVE COMPARATORPatients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cardiology Association of NE Arkansas
Jonesboro, Arkansas, United States
Genesis Heart Institute
Davenport, Iowa, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed. As the study was stopped early, the primary objective is underpowered.
Results Point of Contact
- Title
- Director of Clinical Affairs
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Giudici, MD
Genesis Heart Institute
- PRINCIPAL INVESTIGATOR
F. Roosevelt Gilliam, MD
Cardiology Associates of NE Arkansas
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2008
First Posted
September 23, 2008
Study Start
December 1, 2008
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
June 14, 2017
Results First Posted
June 14, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share