Trial · NCT03970343
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
NCT03970343, Active not recruiting, Impulse Dynamics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy. Trials, record NCT03970343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03970343
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
- NCT number
- NCT03970343
- Status
- Active not recruiting
- Enrollment
- 620 participants, estimated
- Lead sponsor
- Impulse Dynamics
- Conditions
- Heart Failure
- Interventions
- OPTIMIZER Smart System
- First posted
- 2019-05-31
- Last updated
- 2025-11-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of procedure and device-related complications | 1 year | Demonstrate, in the post-approval setting, that the OPTIMIZER Smart is safe to use, by assessing the rate of procedure related complications (30 days) and device related complications (1-year) |
| Primary | All-cause mortality | 3 years | Observed mortality will be compared to the predicted mortality according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant |
| Primary | Procedure related complications | 30-days | Procedure related complications through the end of 30 days following the index procedure |
| Secondary | Cardiovascular hospitalizations | 2 years | Change in cardiovascular hospitalization rate and HF hospitalization rate from 1-year prior to 2 years following index implantation |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03970343
GET https://conductscience.org/api/trials/v1/NCT03970343/registered