Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol

NAEnrolling by invitationINTERVENTIONAL
Enrollment

856

Participants

Timeline

Start Date

December 20, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
High-Risk Percutaneous Coronary Intervention
Interventions
DEVICE

Impella ECP

Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.

Trial Locations (32)

10032

CUMC/ New York Presbyterian Hospital, New York

10075

Lenox Hill Hospital, New York

14203

Buffalo General, Buffalo

23507

Sentara Norfolk Health System, Norfolk

26506

West Virginia University Hospital, Morgantown

30322

Emory University Hospital, Atlanta

33613

AdventHealth - Tampa, Tampa

34208

Manatee Memorial Hospital, Bradenton

North Florida Regional Medical Center, Gainesville

37203

TriStar Centennial Medical Center, Nashville

48202

Henry Ford Hospital, Detroit

48236

Ascension St. John Hospital, Detroit

49503

Spectrum Health, Grand Rapids

56303

St. Cloud (CentraCare), Saint Cloud

59802

Providence St. Patrick, Missoula

70121

Ochsner Foundation Hospital, New Orleans

72211

Arkansas Heart Hospital, Little Rock

73135

Oklahoma Heart Hospital - South, Oklahoma City

75093

Baylor Scott & White The Heart Hospital Plano, Plano

75231

Texas Health Presbyterian Hospital Dallas, Dallas

78229

Methodist Hospital - San Antonio, San Antonio

85013

St. Joseph's Medical Center - Phoenix, Phoenix

85712

Pima Heart & Vascular, Tucson

87102

New Mexico Heart Institute, Albuquerque

90033

Keck Hospital of USC, Los Angeles

91206

Adventist Health Glendale, Glendale

92354

Loma Linda University Medical Center, San Bernardino

97225

Providence St. Vincent Med Center, Portland

02111

Tufts Medical Center, Boston

07601

Hackensack University Medical Ctr, Hackensack

07960

Morristown Medical Center, Morristown

07450

The Valley Hospital, Ridgewood

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Abiomed Inc.

INDUSTRY