Recruiting

Impella RP Flex

Sponsor:

Abiomed Inc.

Code:

NCT06637644

Conditions

Right Ventricular (RV) Dysfunction

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Right-sided ventricular assist device

Study Details

Brief summary:

To capture observational data of the Abiomed Impella RP Flex in a real-world setting.

Conditions

Right Ventricular (RV) Dysfunction

Study ID

NCT06637644

Start date

May 29, 2024

Status verified date

Sep, 2024

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.

Exclusion Criteria:

  • None

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients implanted with right-sided ventricular assist device

Interventions

Right-sided ventricular assist device

Percutaneous device for right heart support

Primary outcome measure

  • Objectives [ Time Frame: 1 year post implant ]

Central Contacts and Locations

Central contacts

Stacie Hallaway, Sr. Clinical Project Manager

839-216-3087shallawa@its.jnj.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85718

Baptist Health Heart Failure and Transplant Institute

Recruiting

Little Rock, Arkansas, United States, 72205

Arkansas Heart Hospital

Recruiting

Little Rock, Arkansas, United States, 72211

University of Southern California (Keck USC)

Recruiting

Los Angeles, California, United States, 90033

Advent Health Orlando

Recruiting

Orlando, Florida, United States, 32803

Tampa General

Recruiting

Tampa, Florida, United States, 33606

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Ascension St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Metropolitan Heart and Vascular Institute

Recruiting

Coon Rapids, Minnesota, United States, 55433

Providence St. Patrick Hospital

Recruiting

Missoula, Montana, United States, 59802

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Rutgers Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901

Montefiore Medical Center - Moses

Recruiting

Bronx, New York, United States, 10467

Northwell Health/Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Novant Health New Hanover Regional Medical Center

Recruiting

Wilmington, North Carolina, United States, 28401

Wake Forest University School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27101

The Lindner Research Center at the Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Legacy Research Institute (Legacy Emanuel Medical Center)

Recruiting

Portland, Oregon, United States, 97232

Oregon Health and Science System

Recruiting

Portland, Oregon, United States, 97239

UPMC Presbyterian

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical City Heart Hospital Dallas

Recruiting

Dallas, Texas, United States, 75243

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Memorial Herman Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

MultiCare Institute for Research Innovation

Recruiting

Puyallup, Washington, United States, 98372

Providence Sacred Heart Medical Center

Recruiting

Spokane, Washington, United States, 99204

Froedtert Hospital (Medical College of Wisconsin)

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Abiomed Inc.

Last update posted

Oct 15, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abiomed Inc. on 2024-10-15.