--- title: Impella Real-World Surveillance of Patients Using Sodium Bicarbonate nct_id: NCT05820451 overall_status: COMPLETED sponsor: Abiomed Inc. study_type: OBSERVATIONAL primary_condition: Cardiogenic Shock countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05820451.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05820451" ct_last_update_post_date: 2024-09-04 last_seen_at: "2026-05-12T06:24:14.114Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Impella Real-World Surveillance of Patients Using Sodium Bicarbonate **NCT ID:** [NCT05820451](https://clinicaltrials.gov/study/NCT05820451) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 312 - **Lead Sponsor:** Abiomed Inc. - **Conditions:** Cardiogenic Shock, High Risk PCI - **Start Date:** 2022-12-15 - **Completion Date:** 2024-02-22 - **CT.gov Last Update:** 2024-09-04 ## Brief Summary The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used. ## Eligibility - **Sex:** ALL - **Healthy Volunteers:** No ``` Left Sided Impella Inclusion Criteria: * Left-sided Impella with bicarbonate in the purge Exclusion Criteria: * Known LV thrombus Right Sided Impella Inclusion Criteria: * Right-sided Impella with bicarbonate in the purge Exclusion Criteria: * Known pulmonary thromboemboli * Known DVT ``` ## Arms - **Left sided device** — All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5. - **Right sided device** — All patients implanted with a right sided support Impella device -this includes the Impella RP ## Interventions - **Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution** (DEVICE) — US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included. - **Impella RP with Sodium Bicarbonate used as purge solution** (DEVICE) — US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included. ## Primary Outcomes - **Primary Endpoint Left Sided Impella** _(time frame: From hospital admission until hospital discharge, average 5 days)_ — Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus - **Primary Endpoint Right Sided Impella** _(time frame: From hospital admission until hospital discharge, average 5 days)_ — Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) ## Locations (20) - University of Alabama, Birmingham, Alabama, United States - Pima Heart and Vascular (Tuscon Medical Center), Tucson, Arizona, United States - Arkansas Heart Hospital, Little Rock, Arkansas, United States - Keck USC Medical Center, Los Angeles, California, United States - Advent Helath Orlando, Orlando, Florida, United States - Tampa General Hospital, Tampa, Florida, United States - Henry Ford, Detroit, Michigan, United States - Ascension St. John Hospital, Detroit, Michigan, United States - Providence St. Patrick, Missoula, Montana, United States - University of Nebraska, Omaha, Nebraska, United States - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States - Christ Hospital, Cincinnatti, Ohio, United States - Montefiore Medical Center - Moses, Portland, Oregon, United States - Legacy Emanuel, Portland, Oregon, United States - Oregon Health & Science University, Portland, Oregon, United States - UPMC Presbyterian, Pittsburgh, Pennsylvania, United States - Baylor Scott and White (Baylor Heart and Vascular), Dallas, Texas, United States - The Heart Hospital Baylor Plano, Plano, Texas, United States - Providence Sacred Heart, Spokane, Washington, United States - MultiCare Tacoma General, Tacoma, Washington, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.university of alabama|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.pima heart and vascular (tuscon medical center)|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.arkansas heart hospital|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.keck usc medical center|los angeles|california|united states` — added _(2026-05-12)_ - `locations.advent helath orlando|orlando|florida|united states` — added _(2026-05-12)_ - `locations.tampa general hospital|tampa|florida|united states` — added _(2026-05-12)_ - `locations.henry ford|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.ascension st. john hospital|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.providence st. patrick|missoula|montana|united states` — added _(2026-05-12)_ - `locations.university of nebraska|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.robert wood johnson university hospital|new brunswick|new jersey|united states` — added _(2026-05-12)_ - `locations.christ hospital|cincinnatti|ohio|united states` — added _(2026-05-12)_ - `locations.montefiore medical center - moses|portland|oregon|united states` — added _(2026-05-12)_ - `locations.legacy emanuel|portland|oregon|united states` — added _(2026-05-12)_ - `locations.oregon health & science university|portland|oregon|united states` — added _(2026-05-12)_ - `locations.upmc presbyterian|pittsburgh|pennsylvania|united states` — added _(2026-05-12)_ - `locations.baylor scott and white (baylor heart and vascular)|dallas|texas|united states` — added _(2026-05-12)_ - `locations.the heart hospital baylor plano|plano|texas|united states` — added _(2026-05-12)_ - `locations.providence sacred heart|spokane|washington|united states` — added _(2026-05-12)_ - `locations.multicare tacoma general|tacoma|washington|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05820451.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05820451* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*