APPROPRIATE - Rate Adaptive Pacing Sensor
This study has been terminated.
(Difficulty in enrollment; higher than planned patient attrition and data attrition)
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00757666
First received: September 19, 2008
Last updated: February 23, 2011
Last verified: February 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Diseases |
Device: Rate adaptive pacemaker |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- Improvement in peak VO2. [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in heart rate during Activities of Daily Living (ADL) using a lift and carry test [ Time Frame: 2 months post-implant ] [ Designated as safety issue: No ]
- Metabolic chronotropic relationship (MCR) slope [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]
- Exercise time [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]
- VO2 at ventilatory threshold [ Time Frame: 1 month and 2 months post-implant ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Accelerometer
|
Device: Rate adaptive pacemaker
Accelerometer sensor
|
|
Active Comparator: 2
Minute ventilation
|
Device: Rate adaptive pacemaker
Minute ventilation sensor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757666
Locations
| United States, Arkansas | |
| Cardiology Association of NE Arkansas | |
| Jonesboro, Arkansas, United States | |
| United States, Iowa | |
| Genesis Heart Institute | |
| Davenport, Iowa, United States | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Principal Investigator: | Michael Giudici, MD | Genesis Heart Institute |
| Principal Investigator: | F. Roosevelt Gilliam, MD | Cardiology Associates of NE Arkansas |
More Information
No publications provided
| Responsible Party: | Director, Clinical Affairs, Boston Scientific CRM |
| ClinicalTrials.gov Identifier: | NCT00757666 History of Changes |
| Other Study ID Numbers: | CR-CA-082808-B |
| Study First Received: | September 19, 2008 |
| Last Updated: | February 23, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Boston Scientific Corporation:
|
Pacemaker |
Additional relevant MeSH terms:
|
Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013