News | May 09, 2017

First Patient Enrolled in Study Examining STEMI Door to LV Unloading Time

Impella CP study to investigate door to left ventricular unloading time

May 9, 2017 — The first patient has been enrolled in the U.S. Food and Drug Administration (FDA) approved prospective feasibility study, STEMI Door-to-Unloading (DTU) with Abiomed Impella CP percutaneous ventricular assist (pVAD) system in acute myocardial infarction. This trial will focus on feasibility and safety of unloading the left ventricle using the Impella CP heart pump prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock with the hypothesis that this will potentially reduce infarct size.

The study, which received FDA approval in October 2016, is a prospective, multi-center feasibility study led by principal investigators Navin K. Kapur, M.D., of Tufts Medical Center and William W. O'Neill, M.D., of Henry Ford Medical Center. Up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months.

The first patient in the study was enrolled in late April at Northwell Health System in Long Island, N.Y.. under the leadership of Perwaiz Meraj, M.D.

The primary endpoints of the feasibility study will focus on safety, including Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days. All patients will undergo cardiac magnetic resonance (CMR) imaging to assess infarct size as percent of left ventricular mass at 30 days post-PCI. Patients will be randomized to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI. The hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and also initiates a cardio-protective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularization. This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites, patients and will be designed for statistical significance. 
Watch the VIDEO “Cardiogenic Shock Supported With Impella Shows Good Outcomes.”

Watch the VIDEO “Demonstration of the Impella Percutaneous Hemodynamic Support Device”

For more information:

Related Content

American College of Cardiology Expands Patient Navigator Program
News | Cath Lab | March 21, 2018
March 21, 2018 — Hundreds of hospitals across the United States will have access to tools and resources to help impro
Videos | Cath Lab | March 15, 2018
A discussion with Hitinder Gurm, M.D., MBBS, FACC, professor, internal medicine, and associate chief clinical officer
News | Cath Lab | February 27, 2018
The American College of Cardiology (ACC) and the Saudi Arabian Cardiac Interventional Society have partnered to...
News | Cath Lab | February 23, 2018
February 23, 2018 — CorFlow Therapeutics AG announced that the company will present new insights into the coronary mi
Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Overlay Init