Chronotropic IncompetenceRAPNCT02003378
Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer
A study testing Pacemaker sensor set to MV and Pacemaker sensor set to XL in people with Chronotropic Incompetence, run by Albany Medical College at 1 site in United States.
Trial summary
Some patients' heart rates do not increase as needed during activities and exercise, which can make them feel tired and fatigued easily. The patients in this study have a pacemaker with a FDA approved rate response sensor, which senses activity level by sensing motion (through a component known as an accelerometer)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronotropic Incompetence
- What is being tested?
- Pacemaker sensor set to MV and Pacemaker sensor set to XL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Willing and capable of providing informed consent for participation
- Previously received, or previously scheduled to receive, dual-chamber/single chamber pacemaker with active atrial and ventricular leads.Boston Scientific Ingenio K172, K173, K174; or (both Ingenio and Advantio have similar rate response features) Advantio K062, K063, K064 (Boston Scientific CRM, St. Paul, MN).
- 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
- Patients with or without one or more of the following are permitted to enroll:
- Sinus node dysfunction with pacemaker
- Mobitz II second degree heart block or third degree heart block with pacemaker
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- Chronic atrial fibrillation and other atrial arrhythmias with controlled heart rate within the past 90 days prior to consent
- Paroxysmal atrial fibrillation on rate controlling medication as long as same rhythm stays throughout the study, sinus or atrial fibrillation.
- Patients with pacemakers requiring beta blocker (or other rate limiting medications) therapy
Who cannot join
- Neuromuscular, orthopedic, or vascular disability that prevents normal walking (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, unstable angina or uncontrolled arrhythmias Severe pulmonary disease with inability to exercise
- Severe heart failure with dyspnea at rest and inability to exercise (NYHA class IV) and qualify for the CRT-D
- 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, or within 30 days prior to consent, enrolled in another investigational study that would directly impact the treatment or outcome of the current study.
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- Younger than 18 years of age
- Patients with pacemakers of unipolar atrial or ventricular lead configuration
- Patients with abdominal pacemaker implants
- Patients on a ventilator
- Patients with a pacemaker with epicardial lead
- Patients with Pneumothorax, pericardial effusion or pleural effusion
- Pregnant or planning to become pregnant during the study (method of assessment upon physician's discretion). Pregnancy test will be done for all female patients of childbearing age before the study, and at each visit.
- Unable or unwilling to comply with the protocol requirements
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Albany Medical College
Albany, New York, 12208
Wendy Stewart, MS, 518-262-9316, stewarw@mail.amc.edu
Sujata Balulad, MD
About this study
Some patients' heart rates do not increase as needed during activities and exercise, which can make them feel tired and fatigued easily. The patients in this study have a pacemaker with a FDA approved rate response sensor, which senses activity level by sensing motion (through a component known as an accelerometer) and/or breathing changes (known as minute ventilation). These changes in motion or breathing make the pacemaker increase the patient's heart rate. This study is being conducted to see which rate response sensor is better (motion driven or breathing driven). The study is also investigating whether optimizing the sensor based on the individual patient will give better results in terms of increasing the patient's exercise capacity. The hypothesis is that rate responsive pacing driven by the minute ventilation sensor results in improved functional capacity compared to accelerometer in chronotropically incompetent patients.
Read the detailed description
This study is a double-blind, randomized, two-arm (with crossover to other arm) trial that will investigate the benefit of rate responsive pacing with either MV or XL in pacemaker patients that have chronotropic incompetence (CI). Blinding will occur for both the patient and the research personnel who are collecting primary endpoint data. The study will enroll patients that have an implanted dual/single chamber pacemaker, which has both the minute ventilation (MV) and accelerometer (XL) rate-adaptive sensors.
The initial study visit called as baseline visit for newly implanted patients (at 2 weeks from implant) and for previously implanted patients (at the time of enrolling in the study).
Patients will complete a 6-min walk test at the baseline study visit to screen for CI based on the intrinsic heart rate achieved during the walk while pacemaker set to DDD/VVI with both sensors set to passive. All patients that are enrolled in the study will get treadmill exercise stress test by chronotropic assessment exercise protocol (CAEP) to confirm CI. Patients will be determined to have CI by completing a maximal effort exercise treadmill stress test with peak perceived exertion by Borg scale of >16 (18) with the pacemaker programmed to DDD/VVI with both device sensors set to passive. Patients that do not meet the criteria of CI after CAEP treadmill test will not continue in the trial.
Patients that have CI will then be randomized in a 1:1 ratio to programming the rate-adaptive sensor to either MV or XL. The MV or XL rate-adaptive sensor will be optimized for each patient using stress test derived age predicted maximum heart rate by adjusting response factor to achieve MCR slope of 1.
At the 4-week visit, patients that have CI will complete a second CAEP treadmill test in their randomized setting with pacer set as DDDR/VVIR. They will also complete 6-minute walk test and pacemaker interrogation. They will be crossed over to the other sensor group at this time by changing the sensor setting.
At 8 week visit, patients will have another CAEP treadmill test, 6-minute walk test and pacemaker interrogation in their randomized crossed over group setting.
Patients that have CI will get quality of life assessment using SF-36 questionnaire and Aquarel questionnaire at baseline visit, 4 and 8 week visit in their randomized setting.
- Conditions
- Chronotropic Incompetence
- Being tested
- Pacemaker sensor set to MV, Pacemaker sensor set to XL
- Keywords
- Chronotropic incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker sensor set to MVDevice
Pacemaker sensor set to minute ventilation
Pacemaker sensor set to XLDevice
Pacemaker sensor set to accelerometer
| Study group | Role | What they receive |
|---|---|---|
| Minute Ventilation (MV) | Active comparator | Pacemaker sensor set to MV (Cross over study) Receives: Device: Pacemaker sensor set to MV |
| Accelerometer (XL) | Active comparator | Pacemaker sensor set to XL (Cross over study) Receives: Device: Pacemaker sensor set to XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic chronotropic relationship (MCR) slope
Improvement in functional capacity, determined by MCR slope - if greater using the minute ventilation senor of the accelerometer sensor in patients with chronotropic incompetence
Measured: 2 weeks, 6 weeks, and 10 weeks post-implant/post enrollment
Secondary outcomes (3)
Changes in heart rate and distance covered during 6-minute walk test
To evaluate the superiority of the minute ventilation sensor or the accelerometer sensor by comparing changes in heart rate and distance covered during activities using a 6 minute walk test.
Measured: 2 weeks, 6 and 10 weeks post-implant/post enrollment
Exercise time during chronotropic assessment exercise protocol (CAEP) stress test
To evaluate the superiority of the minute ventilation sensor or the accelerometer sensor related to exercise time during the CAEP stress test
Measured: 2 weeks, 6 and 10 weeks post-implant/post enrollment
Quality of life (QOL) assessment
SF-36 questionnaire and Aquarel questionnaire to assess quality of life
Measured: 2 weeks, 6 and 10 weeks post-implant/post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronotropic IncompetenceStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Sujata S. Balulad, MD, Albany Medical College
- Investigators
- Sujata Balulad, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003378
- Sponsor's protocol ID
- RAP
- Acronym
- RAP
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physiologic Response With Rate Adaptive Pacing Driven by Minute Ventilation and Accelerometer
- ClinicalTrials.gov ID
- NCT02003378
- Acronym / sponsor ID
- RAP / RAP
- Conditions
- Chronotropic Incompetence
- Keywords
- Chronotropic incompetence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some patients' heart rates do not increase as needed during activities and exercise, which can make them feel tired and fatigued easily. The patients in this study have a pacemaker with a FDA approved rate response sensor, which senses activity level by sensing motion (through a component known as an accelerometer) and/or breathing changes (known as minute ventilation). These changes in motion or breathing make the pacemaker increase the patient's heart rate. This study is being conducted to see which rate response sensor is better (motion driven or breathing driven). The study is also investigating whether optimizing the sensor based on the individual patient will give better results in terms of increasing the patient's exercise capacity. The hypothesis is that rate responsive pacing driven by the minute ventilation sensor results in improved functional capacity compared to accelerometer in chronotropically incompetent patients.
Detailed description
This study is a double-blind, randomized, two-arm (with crossover to other arm) trial that will investigate the benefit of rate responsive pacing with either MV or XL in pacemaker patients that have chronotropic incompetence (CI). Blinding will occur for both the patient and the research personnel who are collecting primary endpoint data. The study will enroll patients that have an implanted dual/single chamber pacemaker, which has both the minute ventilation (MV) and accelerometer (XL) rate-adaptive sensors.
The initial study visit called as baseline visit for newly implanted patients (at 2 weeks from implant) and for previously implanted patients (at the time of enrolling in the study).
Patients will complete a 6-min walk test at the baseline study visit to screen for CI based on the intrinsic heart rate achieved during the walk while pacemaker set to DDD/VVI with both sensors set to passive. All patients that are enrolled in the study will get treadmill exercise stress test by chronotropic assessment exercise protocol (CAEP) to confirm CI. Patients will be determined to have CI by completing a maximal effort exercise treadmill stress test with peak perceived exertion by Borg scale of >16 (18) with the pacemaker programmed to DDD/VVI with both device sensors set to passive. Patients that do not meet the criteria of CI after CAEP treadmill test will not continue in the trial.
Patients that have CI will then be randomized in a 1:1 ratio to programming the rate-adaptive sensor to either MV or XL. The MV or XL rate-adaptive sensor will be optimized for each patient using stress test derived age predicted maximum heart rate by adjusting response factor to achieve MCR slope of 1.
At the 4-week visit, patients that have CI will complete a second CAEP treadmill test in their randomized setting with pacer set as DDDR/VVIR. They will also complete 6-minute walk test and pacemaker interrogation. They will be crossed over to the other sensor group at this time by changing the sensor setting.
At 8 week visit, patients will have another CAEP treadmill test, 6-minute walk test and pacemaker interrogation in their randomized crossed over group setting.
Patients that have CI will get quality of life assessment using SF-36 questionnaire and Aquarel questionnaire at baseline visit, 4 and 8 week visit in their randomized setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minute Ventilation (MV) | Active comparator | Device: Pacemaker sensor set to MVPacemaker sensor set to MV (Cross over study) |
| Accelerometer (XL) | Active comparator | Device: Pacemaker sensor set to XLPacemaker sensor set to XL (Cross over study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and capable of providing informed consent for participation
- Previously received, or previously scheduled to receive, dual-chamber/single chamber pacemaker with active atrial and ventricular leads.Boston Scientific Ingenio K172, K173, K174; or (both Ingenio and Advantio have similar rate response features) Advantio K062, K063, K064 (Boston Scientific CRM, St. Paul, MN).
- 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
- Patients with or without one or more of the following are permitted to enroll:
- Sinus node dysfunction with pacemaker
Key exclusion criteria (14 listed)
- Neuromuscular, orthopedic, or vascular disability that prevents normal walking (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, unstable angina or uncontrolled arrhythmias Severe pulmonary disease with inability to exercise
- Severe heart failure with dyspnea at rest and inability to exercise (NYHA class IV) and qualify for the CRT-D
- 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)
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 |
|---|---|---|
| Pacemaker sensor set to MVPacemaker sensor set to minute ventilation | Device | Minute Ventilation (MV) |
| Pacemaker sensor set to XLPacemaker sensor set to accelerometer | Device | Accelerometer (XL) |
Primary outcome
Metabolic chronotropic relationship (MCR) slope
Time frame: 2 weeks, 6 weeks, and 10 weeks post-implant/post enrollment
Improvement in functional capacity, determined by MCR slope - if greater using the minute ventilation senor of the accelerometer sensor in patients with chronotropic incompetence
3 secondary outcomes
Changes in heart rate and distance covered during 6-minute walk test
Time frame: 2 weeks, 6 and 10 weeks post-implant/post enrollment
Exercise time during chronotropic assessment exercise protocol (CAEP) stress test
Time frame: 2 weeks, 6 and 10 weeks post-implant/post enrollment
Quality of life (QOL) assessment
Time frame: 2 weeks, 6 and 10 weeks post-implant/post enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
Related trials for Chronotropic Incompetence
Recruiting
SHort Of Pace - Heart Failure (SHOP-HF)
Heart Failure With Preserved Ejection Fraction
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.
Sujata Balulad, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker sensor set to MV and Pacemaker sensor set to XL in people with Chronotropic Incompetence, run by Albany Medical College at 1 site 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Stewart, MS (518-262-9316, stewarw@mail.amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic chronotropic relationship (MCR) slope (time frame: 2 weeks, 6 weeks, and 10 weeks post-implant/post enrollment). 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 6 Dec 2013.