Impella RP Flex with Smart Assist

NCT ID: NCT06637644

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-29

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Right Ventricular (RV) Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients implanted with right-sided ventricular assist device

Right-sided ventricular assist device

Intervention Type DEVICE

Percutaneous device for right heart support

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Right-sided ventricular assist device

Percutaneous device for right heart support

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abiomed Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status RECRUITING

Pima Heart and Vascular

Tucson, Arizona, United States

Site Status RECRUITING

Baptist Health Heart Failure and Transplant Institute

Little Rock, Arkansas, United States

Site Status RECRUITING

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Site Status RECRUITING

University of Southern California (Keck USC)

Los Angeles, California, United States

Site Status RECRUITING

Advent Health Orlando

Orlando, Florida, United States

Site Status RECRUITING

Tampa General

Tampa, Florida, United States

Site Status RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Ascension St. John Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Metropolitan Heart and Vascular Institute

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Providence St. Patrick Hospital

Missoula, Montana, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status RECRUITING

Northwell Health/Lenox Hill Hospital

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses

The Bronx, New York, United States

Site Status RECRUITING

Novant Health New Hanover Regional Medical Center

Wilmington, North Carolina, United States

Site Status RECRUITING

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status RECRUITING

The Lindner Research Center at the Christ Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Legacy Research Institute (Legacy Emanuel Medical Center)

Portland, Oregon, United States

Site Status RECRUITING

Oregon Health and Science System

Portland, Oregon, United States

Site Status RECRUITING

UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Medical City Heart Hospital Dallas

Dallas, Texas, United States

Site Status RECRUITING

Baylor University Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Memorial Herman Texas Medical Center

Houston, Texas, United States

Site Status RECRUITING

The Heart Hospital Baylor Plano

Plano, Texas, United States

Site Status RECRUITING

MultiCare Institute for Research Innovation

Puyallup, Washington, United States

Site Status RECRUITING

Providence Sacred Heart Medical Center

Spokane, Washington, United States

Site Status RECRUITING

Froedtert Hospital (Medical College of Wisconsin)

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Stacie Hallaway, Sr. Clinical Project Manager

Role: CONTACT

839-216-3087

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Impella RP Flex Study

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TTVR Early Feasibility Study
NCT04433065 RECRUITING NA