Trial · NCT05855135
Assessment of Combined CCM and ICD Device in HFrEF
NCT05855135, Not applicable, Active not recruiting, Impulse Dynamics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Assessment of Combined CCM and ICD Device in HFrEF. Trials, record NCT05855135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05855135
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of Combined CCM and ICD Device in HFrEF
- NCT number
- NCT05855135
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Impulse Dynamics
- Conditions
Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation
- Interventions
- OPTIMIZER® Integra CCM-D System (Treatment Arm)
- First posted
- 2023-05-11
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective) | Implant | Evaluate the device effectiveness in converting induced VF at the time of implantation. |
| Primary | Device-related Complications (Primary Safety Objective) | Implant to 6 months | Evaluate device-related complications through 6-months (excluding lead-related complications). |
| Secondary | Inappropriate Shock Rate out to 6-months (Secondary Safety Objective) | Implant to 6 months | Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit. |
| Other | Inappropriate Shock Rate out to 2-years | Implant to 2 years | Evaluate the device effectiveness in converting spontaneous VT/VF through the time when the last subject enrolled completes the 6-month visit. Each subject will be followed for 2-years after implant to capture additional spontaneous episodes that may occur. |
| Other | Charging non-compliance | Implant to 2 years | Evaluate subject charging non-compliance defined as \>14 days between interval charging sessions, overall and frequency of non-compliance in the same subject. |
| Other | Longitudinal levels of activity | Implant to 2 years | Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends. |
| Other | Battery degradation and longevity | Implant to 2 years | Assess battery degradation and longevity either remotely or during an in-person follow-up at 2 years (+/- 60 days) by recording QHR battery voltage as measured by the Integra CCM-D IPG. The measurement under nominal conditions is expected to be 2.85V or higher, consistent with a 20-year device longevity. |
| Other | Compare worsening heart failure events pre- and post-implant | 12 months prior to implant and 12 months post-implant | Track unscheduled cardiovascular-related healthcare encounters from 12 months prior to implant, if available, to 12 months post-implant |
| Other | All-cause mortality | 1 and 2 years post-implant | Assess all-cause mortality using Seattle Heart Failure Model (SHFM) and comorbidity burden as a predictive comparator at 1 year and 2 years post-implant |
| Other | Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline to 6-months | Compare change in subject's perception of their heart failure symptoms, as measured by KCCQ, from baseline to 6 months. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT05855135
GET https://conductscience.org/api/trials/v1/NCT05855135/registered