Trial · NCT04069156
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 | Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events | 12 Months | The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant. |
| Secondary | Rates of Non-surgical Major Hemorrhagic Events | Through Study Completion with a Median Follow up of 14 Months | The rate of non-surgical hemorrhagic events were compared between the two arms of the study. Non-surgical Major Hemorrhagic events: Hemorrhagic event rate per patient year was calculated by dividing all non-surgical bleeding events and hemorrhagic stroke events by the cumulative years of study exposure. |
| Secondary | Rates of Bleeding Events | Through Study Completion with a Median Follow up of 14 Months | The bleeding rate was calculated by dividing the number of bleeding events by the cumulative duration of study exposure (years of support). |
| Secondary | Rates of Non-surgical Major Thrombotic Events | Through Study Completion with a Median Follow up of 14 Months | The rates of non-surgical major thrombotic events was compared between the two arms of the study. The thrombotic event rate per patient year was calculated by dividing the number of non-surgical ischemic strokes, pump thrombosis and arterial peripheral thromboembolic events by the cumulative years of study exposure |
| Secondary | Rates of Stroke | Through Study Completion with a Median Follow up of 14 Months | The stroke rate was calculated based on the number of strokes experienced by subjects, 14 days or more after device implant, and while on their treatment assignment, divided by the cumulative duration of study exposure (years of support). |
| Secondary | Survival Rates | 24 Months | The overall survival rate was analyzed using a Kaplan-Meier analysis and the treatment groups were compared using log-rank test. Survival was calculated starting at 14 days post implant. |
| Secondary | Risk of Non-Surgical Bleeding Events | 24 Months | Risk of non-surgical bleeding events was analyzed using a Kaplan-Meier analysis. The treatment groups were compared using a log-rank test. |
| Other | Rate of Rehospitalization | Through Study Completion with a Median Follow up of 14 Months | This study assessed changes in the rehospitalization as a result of removal of antiplatelet therapy from the antithrombotic regimen. |
| Other | Economic Cost Implications - Total Estimated Cost for Bleeding Events (CMS Cost Basis) | 12 Months | Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included. |
| Other | Economic Cost Implications - Average Cost Per Bleeding Event | 12 Months | These values were derived by dividing the total estimated cost for bleeding events by the number of events to determine the average cost per bleeding event. Consequently, a measure of dispersion is not available for these outcomes. |
| Other | Economic Cost Implications - Average Cost Per Study Patient Over the First-year Post-implant | 12 Months | These values were derived by dividing the total estimated cost for bleeding events by the number of patients to obtain the average cost per study patient. Consequently, a measure of dispersion is not available for these outcomes. |
| Other | Economic Cost Implications - Cost of Bleeding Hospitalization for 1000 LVAD Implants Over the First-year Post-implant | 12 Months | Cost of bleeding episodes was calculated based on a previously published economic model, adjusted for inflation using the US Bureau of Labor Statistics Medical Consumer Price Index. To ensure uniformity in care practices and relevance of the previously published model, only US subjects were included. |
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.
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GET https://conductscience.org/api/trials/v1/NCT04069156/registered