Clinical trials: sponsored by Abiomed Inc.
Cardiovascular Diseases
The Global cVAD Study
The intent of the Global cVAD Study is to utilize observational data of the ABIOMED, Inc. hemodynamic support devices in real-world settings to drive best practice usage patterns identified through study analysis, to serve as a…
- Trial name
- cVAD (NCT04136392)
- Testing
- ABIOMED, Inc. hemodynamic support devices
- Where
- 51 sites in United States
- Volunteers
- 20,000 people
- Sponsor
- Abiomed Inc.
ST-elevation Myocardial Infarction
MINI-AMI: Minimizing Infarct Size With Impella 2.5 Following PCI for Acute Myocardial Infarction
A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI)
- Trial name
- MINI-AMI (NCT01319760)
- Testing
- Impella 2.5 support, Standard of care (Control)
- Volunteers
- 5 people
- Sponsor
- Abiomed Inc.
STEMI
Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study
Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
- Trial name
- DTU (NCT03000270)
- Testing
- Impella unloading prior to PPCI
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abiomed Inc.
Heart Failure
Protected PCI Study
A Prospective, multi-center, single-arm post-approval study of the IMPELLA® 2.5 System in Non Emergent High Risk PCI patients.
- Trial name
- NCT02831881
- Where
- United States
- Volunteers
- 369 people
- Sponsor
- Abiomed Inc.
Right Heart Failure
The Use of Impella RP Support System in Patients With Right Heart Failure
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.
- Trial name
- NCT01777607
- Testing
- IMPELLA® RP
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Abiomed Inc.
Heart Failure
Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients
The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in Acute Decompensated Heart Failure patients.
- Trial name
- RELIEF I (NCT01185691)
- Testing
- Impella 2.5
- Volunteers
- 1 people
- Sponsor
- Abiomed Inc.
Chronic Heart Failure
Symphony: The Implantable Counter Pulsation Device (CPD) Safety and Feasibility Trial
The Counter Pulsation Device (CPD) System 'Symphony' is intended to provide counter pulsation therapy for up to thirty (30) days to patients with chronic heart failure who have persistent worsening of their condition despite…
- Trial name
- Symphony (NCT01543022)
- Testing
- Symphony, The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker
- Where
- 3 sites in Canada
- Volunteers
- 10 people
- Sponsor
- Abiomed Inc.
Severe Biventricular End Stage Heart Disease
AbioCor Implantable Replacement Heart
Abiocor is a post market approval study for an Implantable Replacement Heart. This post approval study is currently on hold.
- Trial name
- NCT00669357
- Testing
- Abiocor Implantable Replacement Heart
- Sponsor
- Abiomed Inc.
Acute Cardiac Dysfunction
Voyager I: Patient Discharge Using the AB5000 Portable Driver System
The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of…
- Trial name
- NCT00971776
- Testing
- AB Portable Driver System
- Volunteers
- 9 people
- Sponsor
- Abiomed Inc.
Coronary Artery Disease
Protect II, A Prospective, Multicenter Randomized Controlled Trial
The IMPELLA® 2.5 System will be superior to Intra Aortic Balloon Pump in preventing the composite rate of major adverse events during and after the PCI procedure.
- Trial name
- PROTECT II (NCT00562016)
- Testing
- IMPLELLA LP 2.5, IABP Intra-aortic balloon pump
- Where
- 50 sites in United States, Canada and 1 more
- Volunteers
- 452 people
- Sponsor
- Abiomed Inc.
Patients Undergoing High Risk PCI.
PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI
The objective of this feasibility study is to demonstrate that the device is safe and potentially efficacious for use in patients undergoing high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they…
- Trial name
- PROTECT I (NCT00534859)
- Testing
- High Risk PCI
- Where
- 10 sites in United States, Netherlands
- Volunteers
- 28 people
- Sponsor
- Abiomed Inc.
Acute Myocardial Infarction
Trial Using Impella LP 2.5 System in Patients With Acute Myocardial Infarction Induced Hemodynamic Instability
This is a randomized trial investigating the use of the IMPELLA RECOVER LP 2.5 compared to Intra-aortic balloon pump (IABP) in patients with Acute Myocardial Infarction.
- Trial name
- RECOVER II (NCT00972270)
- Testing
- Impella LP 2.5, Intra-Aortic Balloon Pump
- Where
- 11 sites in United States
- Volunteers
- 1 people
- Sponsor
- Abiomed Inc.
Cardiac Surgery
RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study
To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.
- Trial name
- RECOVER I (NCT00596726)
- Testing
- IMPELLA LP/LD 5.0
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Abiomed Inc.