Status:
TERMINATED
APPROPRIATE - Rate Adaptive Pacing Sensor
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT00757666
Start Date
December 1 2008
End Date
January 1 2011
Last Update
June 14 2017
Active Locations (2)
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1
Cardiology Association of NE Arkansas
Jonesboro, Arkansas, United States
2
Genesis Heart Institute
Davenport, Iowa, United States