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CompletedNCT01643707IMPROVE BradyUpdated Sep 17, 2021Results posted

Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

An observational study in Sinus Node Dysfunction, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 21 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-17.

Sponsored by Medtronic Cardiac Rhythm and Heart Failure (part of Medtronic) · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,342
Ages
18 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • Sinus Node Dysfunction

Keywords

  • Sick Sinus Syndrome
  • Bradycardia
03

In context

Sick Sinus Syndrome

93 studies on the registry are indexed under Sick Sinus Syndrome; 18 are open to participants now.

This study's enrollment of 1,342 is above the median of 300 across 29 observational studies indexed under Sick Sinus Syndrome.

Browse Sick Sinus Syndrome studies →

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 240 studies on the registry; 4 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 18 (95%) have results posted.

Browse Medtronic Cardiac Rhythm and Heart Failure studies →All Medtronic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with possible sinus node dysfunction

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,342 participants (actual)

Groups and cohorts

  • Phase I

    Control

  • Phase II

    Treatment

    Behavioral: Evidence based guidelines and tools

Interventions

  • BehavioralEvidence based guidelines and tools

    Education, guidelines, tools

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 1 year post enrollment

  2. 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

    Time frame: Up to 6 months post diagnosis

Secondary outcomes

  1. 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.

    Time frame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy

  2. Change in Time to Diagnosis of SND Before and After Intervention

    Time to diagnosis days (date of diagnosis - date of enrollment)

    Time frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months

  3. 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)

    Time frame: From date of SND diagnosis until date of therapy, assessed up to 6 months

  4. 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.

    Time frame: between implant visit and 6 months post-implant

  5. 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.

    Time frame: between implant visit and 6 months post-implant

07

Results

Posted Sep 17, 2021
Limitations and caveats
Non-randomized observational study, data collected in a limited region with 10 specialized centers.Assumptions on the effect of pacemaker therapy affordability were limited.QoL increases were not compared to an age and gender-matched control group.

Participant flow

Participant flow — Overall Study
MilestonePhase IPhase II
Started858484
Completed823470
Not completed3514

Outcome measures

PrimaryThe 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

Time frame:
Up to 1 year post enrollment
Reported as:
Count of participants · Participants
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
ParticipantsPhase 1Phase 2
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention368409
Statistical analysis
  • Phase 1 vs Phase 2 · Chi-squared · p = <0.00001
PrimaryThe Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention

Outcome measure applies to subjects that receive a SND diagnosis

Time frame:
Up to 6 months post diagnosis
Reported as:
Count of participants · Participants
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
ParticipantsPhase 1Phase 2
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention63130
Statistical analysis
  • Phase 1 vs Phase 2 · Chi-squared · p = <0.0001
SecondaryThe 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.

Time frame:
SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Reported as:
Count of participants · Participants
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
ParticipantsPhase 1Phase 2
Subjects Diagnosed368409
Subjects Implanted63130
Statistical analysis
  • Phase 1 vs Phase 2 · Chi-squared · p = <0.0001 (This endpoint was covered in primary objective 2, so this analysis is the same as previously reported.)
SecondaryChange in Time to Diagnosis of SND Before and After Intervention

Time to diagnosis days (date of diagnosis - date of enrollment)

Time frame:
From date of enrollment until date of SND diagnosis, assessed up to 60 months
Reported as:
Count of participants · Participants
Change in Time to Diagnosis of SND Before and After Intervention
ParticipantsPhase 1Phase 2
0 Months (or Prior to Enrollment)126232
Prior to 1 Month168156
1-2 Months107
2-3 Months74
3-4 Months61
4-5 Months23
5-6 Months22
Greater than 6 Months474
SecondaryChange 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)

Time frame:
From date of SND diagnosis until date of therapy, assessed up to 6 months
Reported as:
Count of participants · Participants
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
ParticipantsPhase 1Phase 2
0 Months or Prior to Implant2252
Prior to 1 Month3774
1-2 Months10
2-3 Months02
Greater than 3 Months32
SecondaryDifference 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.

Time frame:
between implant visit and 6 months post-implant
Reported as:
Mean · difference of score on the SF-12 scale
Difference in QoL Between Implant Visit and 6 Months Post-implant
difference of score on the SF-12 scalePhase 2 QoL Cohort
SF-12 Physical Component11.7 ± 8.1
SF-12 Mental Component10.2 ± 10.6
SecondaryChange 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.

Time frame:
between implant visit and 6 months post-implant
Reported as:
Mean · change in score on Zarit QoL scale
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
change in score on Zarit QoL scalePhase 2 QoL Cohort
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant-14.7 ± 15.7

Adverse events

Collected over Study duration lasted 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase I2/847 (0.2%)——
Phase II1/470 (0.2%)——

Baseline characteristics

Phase 1, the control phase, we expect to obtain baseline measurements for key variables including the rate of SND diagnosis and the rate of implantation of an IPG in subjects with an SND diagnosis.2nd phase, the experimental phase, patients will have scheduled follow-up to collect questionnaire data if they are implanted with an IPG.

Age, Continuous
Age, Continuous(years)Phase IPhase IITotal
Mean60.0 ± 16.057.9 ± 14.959.3 ± 15.6
Sex: Female, Male
Sex: Female, Male(Participants)Phase IPhase IITotal
Female277128405
Male546342888
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Phase IPhase IITotal
Race/Ethnic Origin — Subject/Physician Chose not to provide information202
Race/Ethnic Origin — Not reportable per local laws or regulations101
Race/Ethnic Origin — American Indian or Alaska Native000
Race/Ethnic Origin — Asian59106165
Race/Ethnic Origin — Black or African American000
Race/Ethnic Origin — Hispanic or Latino1630163
Race/Ethnic Origin — Native Hawaiian or Pacific Islander000
Race/Ethnic Origin — White or Caucasian1420142
Race/Ethnic Origin — Indian444345789
Race/Ethnic Origin — Two or More Races101
Race/Ethnic Origin — Other101929
Race/Ethnic Origin — Unknown/Not Reported101
08

Study locations

21 sites
  • Hospital General de Agudos
    Buenos Aires, Argentina
  • National Heart Foundation Hospital and Research Institute
    Dhaka, Bangladesh
  • United Hospital Limited
    Dhaka, Bangladesh
  • CARE Hospitals
    Hyderabad, Andhra Pradesh, India
  • Max Balaji Hospital
    New Delhi, DL, India
  • Care Insitute of Medical Sciences
    Ahmedabad, Gujarat, India
  • RajaRajeswari Medical College & Hospital
    Bangalore, Karnataka, India
  • Madras Medical Mission Institute of Cardiovascular Diseases
    Chennai, Tamil Nadu, India
  • King George's Medical University
    Lucknow, Uttar Pradesh, India
  • The Mission Hospital
    Durgapur, West Bengal, India
  • Max Devki Devi Heart and Vascular Institute
    Delhi, India
  • Centro Medico Nacional de Occidente IMSS
    Mexico City, Mexico
  • Hospital Central Militar
    Mexico City, Mexico
  • UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS
    Mexico City, Mexico
  • Hospital Nacional Carlos Alberto Seguín Escobedo
    Arequipa, Peru
  • Instituto Nacional Cardiovascular
    Lima, Peru
  • Amur State Medical Academy
    Amur, Amur Oblast 675006, Russian Federation
  • Chelyabinsk Federal Center of Cardiovascular Surgery
    Chelyabinsk, 454003, Russian Federation
  • Federal Center of Cardio-Vascular Surgery
    Krasnoyarsk, 660020, Russian Federation
  • Center of Modern Cardiology
    Krasnoyarsk, 660093, Russian Federation
  • Casa de Galicia
    Montevideo, Uruguay
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2012 to primary completion in Jan 2019, 78 months.

Results were first posted in Sep 2021, 2 years 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2012
First posted
Jul 18, 2012
StartActual
Jul 2012
Primary completionActual
Jan 30, 2019
CompletionActual
Jan 31, 2019
Results first posted
Sep 17, 2021
Last update
Sep 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01643707
Lead sponsor
Medtronic Cardiac Rhythm and Heart Failure
Responsible party
Sponsor
First posted
Jul 18, 2012
Start date
Jul 2012
Primary completion
Jan 30, 2019
Completion
Jan 31, 2019
Results posted
Sep 17, 2021
Last update
Sep 17, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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