Trial · NCT05855135
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | EQ-5D-5L | Baseline to 6-months | Compare change in subject's perception of their health status, as measured by the EQ-5D-5L, from baseline to 6 months. |
| Other | Six Minute Walk Distance (6MWD) | Baseline to 6 months | Compare change in functional capacity, as measured by 6MWD, from baseline to 6 months. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05855135/registered