Clinical trials: sponsored by Abiomed Inc.
AMI Cardiogenic Shock
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with…
- Trial name
- OASIS-AMICS (NCT06964685)
- Testing
- Impella
- Where
- 21 sites in United States
- Volunteers
- 350 people
- Sponsor
- Abiomed Inc.
Heart Failure, Cardiogenic Shock
INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
- Conditions
- Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure
- Trial name
- INTeGRATE (NCT06965504)
- Testing
- Impella 5.5 SmartAssist
- Where
- 17 sites in United States
- Volunteers
- 250 people
- Sponsor
- Abiomed Inc.
High-risk Percutaneous Coronary Intervention
Impella ECP Early Feasibility Study
The Impella ECP EFS is a prospective, multicenter, single-arm, feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention.
- Trial name
- ECP EFS (NCT04477603)
- Testing
- Impella ECP
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
Left Ventricular Dysfunction
IMpella-Protected cArdiaC Surgery Trial (IMPACT)
The purpose of this Trial is to demonstrate the safety and effectiveness of the use of Impella 5.5 in high-risk cardiac surgery patients, with the overall aim to evaluate if using Impella 5.5 with SmartAssist (Impella 5.5)…
- Trial name
- IMPACT (NCT05529654)
- Testing
- Impella 5.5 with SmartAssist
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Abiomed Inc.
Left Ventricular Dysfunction, Coronary Artery Disease
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health…
- Trial name
- PROTECT IV (NCT04763200)
- Testing
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Where
- 110 sites in United States, Canada and 5 more
- Volunteers
- 1,252 people
- Sponsor
- Abiomed Inc.
Cardiogenic Shock
Abiomed Impella RT-DAQ - Observational Study
Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
- Trial name
- NCT06308055
- Testing
- Data Acquisition
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 125 people
- Sponsor
- Abiomed Inc.
ST Elevation (STEMI) Myocardial Infarction of Anterior Wall
Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial
The purpose of this research study is to evaluate whether using the the IMPELLA® CP System temporary circulatory assist device for 30 minutes prior to a catheterization procedure has the potential to reduce the damage to the…
- Trial name
- DTU-STEMI (NCT03947619)
- Testing
- Impella CP® placement prior to reperfusion with Primary PCI
- Where
- 63 sites in United States, Canada and 4 more
- Volunteers
- 527 people
- Sponsor
- Abiomed Inc.
High-Risk Percutaneous Coronary Intervention
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or…
- Trial name
- NCT05334784
- Testing
- Impella ECP
- Where
- 32 sites in United States
- Volunteers
- 856 people
- Sponsor
- Abiomed Inc.
Heart Failure, Acute Decompensated Heart Failure
Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study
This is a prospective, multi-center, single-arm, early feasibility study that aims to evaluate the safety of the Impella BTR™ in adult patients requiring left-ventricular hemodynamic support, and to evaluate the effectiveness of…
- Trial name
- BTR EFS (NCT05291884)
- Testing
- Impella BTR
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Abiomed Inc.
Heart Failure
Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps
Analysis of cell and protein deposits on the Impella Heart Pump.
- Trial name
- NCT06765226
- Where
- 7 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Abiomed Inc.
Acute Decompensated Heart Failure, Acute Heart Failure
SVC Occlusion in Subjects With Acute Decompensated Heart Failure
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
- Conditions
- Acute Decompensated Heart Failure, Acute Heart Failure, Congestive Heart Failure, Heart Diseases
- Trial name
- VENUS-HF (NCT03836079)
- Testing
- preCARDIA system
- Where
- 17 sites in United States
- Volunteers
- 60 people
- Sponsor
- Abiomed Inc.
Left Ventricular Dysfunction
IMPACT EU Post-Market Clinical Follow-Up Study
The purpose of this trial is to collect further data on the safety and on the effectiveness of the use of Impella 5.5® in high-risk cardiac surgery patients.
- Trial name
- NCT05756751
- Testing
- Device: Impella 5.5 with SmartAssist
- Where
- 13 sites in Czechia, Germany
- Volunteers
- 123 people
- Sponsor
- Abiomed Inc.
Heart Failure
V-A ECMO AUTO Mode Registry
Abiomed Impella V-A ECMO AUTO Mode - Observational Study
- Trial name
- NCT05759377
- Testing
- V-A ECMO AUTO Mode algorithm
- Where
- 6 sites in Germany
- Volunteers
- 46 people
- Sponsor
- Abiomed Inc.
Cardiogenic Shock, Acute Decompensated Heart Failure
SURPASS Impella 5.5 Study
A multi-center, prospective \& retrospective, observational single-arm study of the clinical outcomes up to one year collected from electronic health records of patients which have undergone standard of care implantation of…
- Trial name
- NCT05100836
- Testing
- Impella 5.5
- Where
- 15 sites in United States
- Volunteers
- 1,017 people
- Sponsor
- Abiomed Inc.
ST-segment Elevation Myocardial Infarction (STEMI), Cardiogenic Shock
The RECOVER IV Trial
The purpose of this study is to assess whether hemodynamic support with an Impella-based treatment strategy initiated prior to percutaneous coronary intervention (PCI) in patients with ST-Segment Elevation Myocardial Infarction…
- Trial name
- RECOVER IV (NCT05506449)
- Testing
- Impella CP®, Standard of Care
- Where
- 7 sites in United States, Denmark and 2 more
- Volunteers
- 4 people
- Sponsor
- Abiomed Inc.
Right Ventricular (RV) Dysfunction
Impella RP Flex with Smart Assist
To capture observational data of the Abiomed Impella RP Flex in a real-world setting.
- Trial name
- NCT06637644
- Testing
- Right-sided ventricular assist device
- Where
- 31 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abiomed Inc.
Cardiopulmonary Bypass, ARDS
Breethe Abiomed Recovery RegisTry (BART)
The BART Registry intended to utilize observational data of the Abiomed Breethe OXY-1 System™ in real-world settings to drive best practice usage patterns, serve as a tool to measure and improve the quality of patient care and as…
- Conditions
- Cardiopulmonary Bypass, ARDS, Heart Failure
- Trial name
- BART (NCT05473130)
- Testing
- Breethe Oxy-1 System
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Abiomed Inc.
Cardiogenic Shock, High Risk PCI
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
- Trial name
- NCT05820451
- Testing
- Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution, Impella RP with Sodium Bicarbonate used as purge solution
- Where
- 20 sites in United States
- Volunteers
- 312 people
- Sponsor
- Abiomed Inc.
Cardiac Output
The Smart Pump Study
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods.
- Trial name
- NCT04465201
- Testing
- Impella CP with Smart Assist (Circulatory Support System)
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Abiomed Inc.
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.