BradycardiaPhase 4NCT00146861
LIFE Study - Limiting Chronotropic Incompetence for Pacemaker Recipients
A Phase 4 study testing sensor programming in people with Bradycardia, run by Boston Scientific Corporation.
Trial summary
This study will compare how two different sensors inside the pacemaker may affect patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- sensor programming
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Jan 2006
- Phase
- Phase 4
- 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
- Patients who meet current INSIGNIATM Plus pacemaker indications
- Patients who sign and date a Patient Informed Consent prior to device implant
- Patients who remain in the clinical care of the enrolling physician
Who cannot join
- Patients whose previous pacemaker had a minute ventilation sensor
- Patients who have neuromuscular, orthopedic, or vascular disability that prevents normal walking (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
- Patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease
- Uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled)
- Patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode (i.e., DDD or DDDR)
- Patients whose life expectancy is less than 12-months due to other medical conditions
Show all 12Show fewer
- Patients who have or who are indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D)
- Patients who have active chronic leads that are either single-pass VDD, unipolar ventricular and atrial, non-IS-1, and non-3.2mm UNLESS the leads are replaced with bipolar leads that are IS-1/3.2mm compatible
- Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study. Each instance should be brought to the attention of Guidant's Clinical Application Research Studies (CARS) group to determine eligibility
- Patients who are younger than 18 years of age
- Patients who are pregnant
- Patients who are mentally incompetent and cannot sign a Patient Informed Consent or participate in the study
About this study
Official title: Limiting Chronotropic Incompetence for Pacemaker Recipients
This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.
Read the detailed description
The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared. A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer.
- Conditions
- Bradycardia
- Being tested
- sensor programming
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensor programmingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence of CI among a general sample of pacemaker patients, compare differences in quality of life and physical activity between patients programmed to either blended sensor or accelerometer
Secondary outcomes (1)
Evaluate changes in chronotropic response among CI patients who are randomized to receive adaptive rate therapy driven by either blended sensor or accelerometer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Coman, MD, Principal investigator, Oklahoma Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146861
- Sponsor's protocol ID
- CR-CA-062703-B
- Status last verified
- May 2017
- First submitted
- 2 Sep 2005
- Last updated
- 18 May 2017
- Results posted
- No
Publications
Richards M, Olshansky B, Sharma AD, Wold N, Jones P, Perschbacher D, Wilkoff BL. Addition of minute ventilation to rate-response pacing improves heart rate score more than accelerometer alone. Heart Rhythm. 2018 Nov;15(11):1730-1735. doi: 10.1016/j.hrthm.2018.06.021. Epub 2018 Jun 13.
PubMed 29908371
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Limiting Chronotropic Incompetence for Pacemaker Recipients
- ClinicalTrials.gov ID
- NCT00146861
- Acronym / sponsor ID
- CR-CA-062703-B
- Conditions
- Bradycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2003 (actual)
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 7 Sep 2005 (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.
This study will compare how two different sensors inside the pacemaker may affect patients' quality of life.
Detailed description
The LIFE Study will estimate the prevalence of CI among a general sample of pacemaker patients and compare changes in quality of life and physical activity between patients randomized to receive rate response driven by either blended sensor or accelerometer. Changes in chronotropic response between CI patients randomized to either blended sensor or accelerometer will be compared. A sub-study will evaluate changes in functional capacity between CI patients randomized to either blended sensor or accelerometer.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who meet current INSIGNIATM Plus pacemaker indications
- Patients who sign and date a Patient Informed Consent prior to device implant
- Patients who remain in the clinical care of the enrolling physician
Key exclusion criteria (12 listed)
- Patients whose previous pacemaker had a minute ventilation sensor
- Patients who have neuromuscular, orthopedic, or vascular disability that prevents normal walking (e.g., intermittent claudication, arthritis, residual stroke weakness, need for a wheelchair or walker)
- Patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease
- Uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled)
- Patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode (i.e., DDD or DDDR)
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 |
|---|---|---|
| sensor programming | Device | – |
Primary outcome
Determine the prevalence of CI among a general sample of pacemaker patients, compare differences in quality of life and physical activity between patients programmed to either blended sensor or accelerometer
1 secondary outcome
Evaluate changes in chronotropic response among CI patients who are randomized to receive adaptive rate therapy driven by either blended sensor or accelerometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Derived from this study: PubMed 29908371Richards M, Olshansky B, Sharma AD, Wold N, Jones P, Perschbacher D, Wilkoff BL. Addition of minute ventilation to rate-response pacing improves heart rate score more than accelerometer alone. Heart Rhythm. 2018 Nov;15(11):1730-1735. doi: 10.1016/j.hrthm.2018.06.021. Epub 2018 Jun 13.
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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.
James Coman, MD principal investigator
Oklahoma Heart Institute
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sensor programming in people with Bradycardia, run by Boston Scientific Corporation.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the prevalence of CI among a general sample of pacemaker patients, compare differences in quality of life and physical activity between patients programmed to either blended sensor or accelerometer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146861, which also lists 1 linked publication.
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 18 May 2017.