Sinus Node DysfunctionIMPROVE BradyNCT01643707
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
An observational study of Sinus Node Dysfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 21 sites in 7 countries.
Trial summary
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinus Node Dysfunction
- What is being tested?
- Evidence based guidelines and tools
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,342 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Jul 2012to 31 Jan 2019
- Phase
- Observational
- 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
Study population: Patients with possible sinus node dysfunction
Who may be able to join
- Patient is at least 18 years of age
- Patient's heart rate meets at least one of the following:
- Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50
- Patient has a history of exercise intolerance
- Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia).
- Patient (or patient's legally authorized representative) is willing and able to sign and date written Patient Consent Form/Patient Data Release Consent
Who cannot join
- Patient has type II 2nd degree AV block, High degree AV block (2:1, 3:1, 4:1 etc.) or 3rd degree AV block
- Patient has recent history of blood loss
- Patient has a medical history leading to suspicion of neurological disorder
- Patient has a history of Chronic Atrial Fibrillation
- Patient is enrolled or planning to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from the Medtronic study manager
- Patient is not expected to survive for 12 months
- Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
India8 sites
Care Insitute of Medical Sciences
Ahmedabad, Gujarat
RajaRajeswari Medical College & Hospital
Bangalore, Karnataka
Madras Medical Mission Institute of Cardiovascular Diseases
Chennai, Tamil Nadu
Max Devki Devi Heart and Vascular Institute
Delhi
The Mission Hospital
Durgapur, West Bengal
CARE Hospitals
Hyderabad, Andhra Pradesh
King George's Medical University
Lucknow, Uttar Pradesh
Max Balaji Hospital
New Delhi, National Capital Territory of Delhi
Russia4 sites
Amur State Medical Academy
Amur, Amur Oblast, 675006
Chelyabinsk Federal Center of Cardiovascular Surgery
Chelyabinsk, 454003
Federal Center of Cardio-Vascular Surgery
Krasnoyarsk, 660020
Center of Modern Cardiology
Krasnoyarsk, 660093
Mexico3 sites
Centro Medico Nacional de Occidente IMSS
Mexico City
Hospital Central Militar
Mexico City
UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS
Mexico City
Bangladesh2 sites
National Heart Foundation Hospital and Research Institute
Dhaka
United Hospital Limited
Dhaka
Peru2 sites
Hospital Nacional Carlos Alberto Seguín Escobedo
Arequipa
Instituto Nacional Cardiovascular
Lima
About this study
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Read the detailed description
The study is expected to provide evidence to support claim(s) that:
- Education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (SND)
- The quality improvement methods studied have general applicability and can be used by all centers
- Appropriate treatment minimizes caregiver burden
- Appropriate treatment improves quality of life (QOL) and functional status compared to pre-implant
- Conditions
- Sinus Node Dysfunction
- Being tested
- Evidence based guidelines and tools
- Keywords
- Sick Sinus Syndrome, Bradycardia
- Medical subject headings
- Sick Sinus Syndrome, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence based guidelines and toolsBehavioural
Education, guidelines, tools
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Control | |
| Phase II | Treatment Receives: Behavioral: Evidence based guidelines and tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
The absolute change in the proportion of subjects diagnosed with SND before and after intervention
Measured: Up to 1 year post enrollment
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
Outcome measure applies to subjects that receive a SND diagnosis
Measured: Up to 6 months post diagnosis
Secondary outcomes (5)
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy.
Measured: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Change in Time to Diagnosis of SND Before and After Intervention
Time to diagnosis days (date of diagnosis - date of enrollment)
Measured: From date of enrollment until date of SND diagnosis, assessed up to 60 months
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
Time to implant in days (date of implant - date of diagnosis)
Measured: From date of SND diagnosis until date of therapy, assessed up to 6 months
Difference in QoL Between Implant Visit and 6 Months Post-implant
The difference in quality of life was assessed using the SF-12 survey, with higher numbers indicating a better quality of life for the patient. The possible physical score ranges are between 24.0 and 56.6. The possible mental score ranges are between 19.1 and 60.8. Only the difference over time was reported.
Measured: between implant visit and 6 months post-implant
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
The difference in caregiver burden was assessed using a Zarit survey, with lower numbers indicating a decreased burden or a better outcome for the caregiver. The possible range of scores was between 0 and 88. Only the difference in scores over time were reported.
Measured: between implant visit and 6 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 posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completion30 Jan 2019
- Study completion31 Jan 2019
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 Sinus Node DysfunctionStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643707
- Sponsor's protocol ID
- IMPROVE Brady
- Acronym
- IMPROVE Brady
- Status last verified
- Sep 2021
- First submitted
- 28 Jun 2012
- Last updated
- 17 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
- ClinicalTrials.gov ID
- NCT01643707
- Acronym / sponsor ID
- IMPROVE Brady / IMPROVE Brady
- Conditions
- Sinus Node Dysfunction
- Keywords
- Sick Sinus Syndrome, Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,342 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 17 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Detailed description
The study is expected to provide evidence to support claim(s) that:
- Education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (SND)
- The quality improvement methods studied have general applicability and can be used by all centers
- Appropriate treatment minimizes caregiver burden
- Appropriate treatment improves quality of life (QOL) and functional status compared to pre-implant
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | –Control |
| Phase II | – | Behavioral: Evidence based guidelines and toolsTreatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with possible sinus node dysfunction
Key inclusion criteria (6 listed)
- Patient is at least 18 years of age
- Patient's heart rate meets at least one of the following:
- Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia).
- Patient (or patient's legally authorized representative) is willing and able to sign and date written Patient Consent Form/Patient Data Release Consent
Key exclusion criteria (7 listed)
- Patient has type II 2nd degree AV block, High degree AV block (2:1, 3:1, 4:1 etc.) or 3rd degree AV block
- Patient has recent history of blood loss
- Patient has a medical history leading to suspicion of neurological disorder
- Patient has a history of Chronic Atrial Fibrillation
- Patient is enrolled or planning to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from the Medtronic study manager
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 |
|---|---|---|
| Evidence based guidelines and toolsEducation, guidelines, tools | Behavioural | Phase II |
Primary outcome
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
Time frame: Up to 1 year post enrollment
The absolute change in the proportion of subjects diagnosed with SND before and after intervention
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
Time frame: Up to 6 months post diagnosis
Outcome measure applies to subjects that receive a SND diagnosis
5 secondary outcomes
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
Time frame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Change in Time to Diagnosis of SND Before and After Intervention
Time frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
Time frame: From date of SND diagnosis until date of therapy, assessed up to 6 months
Difference in QoL Between Implant Visit and 6 Months Post-implant
Time frame: between implant visit and 6 months post-implant
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
Time frame: between implant visit and 6 months post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Node Dysfunction, run by Medtronic Cardiac Rhythm and Heart Failure at 21 sites in 7 countries.
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 6 inclusion and 7 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 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in India, Russia, Mexico, Bangladesh, Peru and 2 more countries. 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 17 Sep 2021). 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?
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention (time frame: Up to 1 year post enrollment). The study lists 2 primary outcomes in all. 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 17 Sep 2021.