Heart DiseasesAPPROPRIATENCT00757666
APPROPRIATE - Rate Adaptive Pacing Sensor
A study testing Rate adaptive pacemaker in people with Heart Diseases, run by Boston Scientific Corporation at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Rate adaptive pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Genesis Heart Institute
Davenport, Iowa
Cardiology Association of NE Arkansas
Jonesboro, Arkansas
About this study
Official title: Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer
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).
- Conditions
- Heart Diseases
- Being tested
- Rate adaptive pacemaker
- Keywords
- Pacemaker
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rate adaptive pacemakerDevice
Accelerometer sensor
Rate adaptive pacemakerDevice
Minute ventilation sensor
| Study group | Role | What they receive |
|---|---|---|
| Accelerometer | Active comparator | Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor. Receives: Device: Rate adaptive pacemaker |
| Minute Ventilation | Active comparator | Patients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor. Receives: Device: Rate adaptive pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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
This outcome measure will be compared against baseline.
Measured: 2 months post-implant
Metabolic Chronotropic Relationship (MCR) Slope
Measured: 1 month and 2 months post-implant
Exercise Time
Measured: 1 month and 2 months post-implant
VO2 at Ventilatory Threshold
Measured: 1 month and 2 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Difficulty enrollment; higher than planned patient attrition and data attrition
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Giudici, MD, Principal investigator, Genesis Heart InstituteF. Roosevelt Gilliam, MD, Principal investigator, Cardiology Associates of NE Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757666
- Sponsor's protocol ID
- CR-CA-082808-B
- Acronym
- APPROPRIATE
- Status last verified
- May 2017
- First submitted
- 19 Sep 2008
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Proper Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation or Accelerometer
- ClinicalTrials.gov ID
- NCT00757666
- Acronym / sponsor ID
- APPROPRIATE / CR-CA-082808-B
- Conditions
- Heart Diseases
- Keywords
- Pacemaker
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrollment; higher than planned patient attrition and data attrition
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2008 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Sep 2008 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerometer | Active comparator | Device: Rate adaptive pacemakerPatients implanted with a Boston Scientific ALTRUA 60 pacemaker with accelerometer (motion-based) sensor. |
| Minute Ventilation | Active comparator | Device: Rate adaptive pacemakerPatients implanted with a Boston Scientific ALTRUA 60 pacemaker with minute ventilation sensor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rate adaptive pacemakerAccelerometer sensor | Device | Accelerometer |
| Rate adaptive pacemakerMinute ventilation sensor | Device | Minute Ventilation |
Primary outcome
Mean Change in Functional Capacity (Peak VO2).
Time frame: 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.
4 secondary outcomes
Changes in Heart Rate During Activities of Daily Living (ADL) Using a Lift and Carry Test
Time frame: 2 months post-implant
Metabolic Chronotropic Relationship (MCR) Slope
Time frame: 1 month and 2 months post-implant
Exercise Time
Time frame: 1 month and 2 months post-implant
VO2 at Ventilatory Threshold
Time frame: 1 month and 2 months post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Diseases
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Active, not recruiting
Insulin Resistance and Coronary Microvascular Dysfunction in Patients With Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Coronary Microvascular Dysfunction, Coronary Microvascular Disease
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Giudici, MD principal investigator
Genesis Heart Institute
F. Roosevelt Gilliam, MD principal investigator
Cardiology Associates of NE Arkansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rate adaptive pacemaker in people with Heart Diseases, run by Boston Scientific Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Functional Capacity (Peak VO2). (time frame: 1 month and 2 months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.