Trial · NCT01643707
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
NCT01643707, Completed, Medtronic Cardiac Rhythm and Heart Failure; results first posted 2021-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady). Trials, record NCT01643707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01643707
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
- NCT number
- NCT01643707
- Status
- Completed
- Enrollment
- 1,342 participants, actual
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Conditions
- Sinus Node Dysfunction
- Interventions
- Evidence based guidelines and tools
- First posted
- 2012-07-18
- Last updated
- 2021-09-17
- Results first posted
- 2021-09-17
- 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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | Up to 1 year post enrollment | The absolute change in the proportion of subjects diagnosed with SND before and after intervention |
| Primary | The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Up to 6 months post diagnosis | Outcome measure applies to subjects that receive a SND diagnosis |
| Secondary | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy | Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy. |
| Secondary | Change in Time to Diagnosis of SND Before and After Intervention | From date of enrollment until date of SND diagnosis, assessed up to 60 months | Time to diagnosis days (date of diagnosis - date of enrollment) |
| Secondary | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | From date of SND diagnosis until date of therapy, assessed up to 6 months | Time to implant in days (date of implant - date of diagnosis) |
| Secondary | Difference in QoL Between Implant Visit and 6 Months Post-implant | 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. |
| Secondary | Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | Up to 1 year post enrollment | Only sites in South Asia participated in both Phase 1 and Phase 2, as such those subjects were included for objective analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Up to 6 months post diagnosis | Subjects with an SND diagnosis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy | Only subjects diagnosed in each phase with SND. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Time to Diagnosis of SND Before and After Intervention | From date of enrollment until date of SND diagnosis, assessed up to 60 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention | From date of SND diagnosis until date of therapy, assessed up to 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Difference in QoL Between Implant Visit and 6 Months Post-implant | between implant visit and 6 months post-implant | Only subjects receiving a Medtronic device with both Implant and 6 Month data were included | difference of score on the SF-12 scale | MEAN |
| SECONDARY | Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant | between implant visit and 6 months post-implant | Only subjects receiving a Medtronic device with both Implant and 6 Month data were included | change in score on Zarit QoL scale | MEAN |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | Phase 1 | 368 | Participants | ||
| The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | Phase 2 | 409 | Participants | ||
| The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Phase 1 | 63 | Participants | ||
| The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Phase 2 | 130 | Participants | ||
| The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Phase 1 | Subjects Diagnosed | 368 | Participants | |
| The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Phase 2 | Subjects Diagnosed | 409 | Participants | |
| The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Phase 1 | Subjects Implanted | 63 | Participants | |
| The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy | Phase 2 | Subjects Implanted | 130 | Participants | |
| Change in Time to Diagnosis of SND Before and After Intervention | Phase 1 | 0 Months (or Prior to Enrollment) | 126 | Participants | |
| Change in Time to Diagnosis of SND Before and After Intervention | Phase 2 | 0 Months (or Prior to Enrollment) | 232 | Participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I | 858 | |
| Overall Study | STARTED | Phase II | 484 | |
| Overall Study | COMPLETED | Phase I | 823 | |
| Overall Study | COMPLETED | Phase II | 470 | |
| Overall Study | NOT COMPLETED | Phase I | 35 | |
| Overall Study | NOT COMPLETED | Phase II | 14 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I | 2 | 847 |
| Total, all-cause mortality | Phase II | 1 | 470 |
| Total, other adverse events | Phase I | 0 | 0 |
| Total, other adverse events | Phase II | 0 | 0 |
| Total, serious adverse events | Phase I | 0 | 0 |
| Total, serious adverse events | Phase II | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase 1 vs Phase 2: The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention | Trial comparisons |
| Phase 1 vs Phase 2: The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention | Trial comparisons |
| Phase I vs Phase II: deaths from any cause | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01643707
GET https://conductscience.org/api/trials/v1/NCT01643707/results?page=2