Observational data collection of the Impella RP Flex device
Impella RP Flex Registry
This study is looking to see how well the Impella RP Flex device works and keeps patients safe while helping those with right heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Abiomed Inc. Industry-sponsored |
| Locations | 31 sites (Birmingham, Alabama and 30 other locations) |
| Trial ID | NCT06637644 on ClinicalTrials.gov |
What this trial studies
This study aims to gather observational data on the use of the Abiomed Impella RP Flex device in patients experiencing right ventricular dysfunction. By monitoring real-world outcomes, the study seeks to understand the effectiveness and safety of this right-sided ventricular assist device. Participants will include individuals who have received mechanical circulatory support with the Impella RP Flex, allowing for a comprehensive assessment of its performance in clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have received mechanical circulatory support with the Impella RP Flex device.
Not a fit: Patients who have not received the Impella RP Flex device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Impella RP Flex device for patients with right ventricular dysfunction.
How similar studies have performed: While this study is observational, similar approaches in monitoring device performance have shown promise in other clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry. Exclusion Criteria: * None
Where this trial is running
Birmingham, Alabama and 30 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Pima Heart and Vascular — Tucson, Arizona, United States (Recruiting)
- Baptist Health Heart Failure and Transplant Institute — Little Rock, Arkansas, United States (Recruiting)
- Arkansas Heart Hospital — Little Rock, Arkansas, United States (Recruiting)
- University of Southern California (Keck USC) — Los Angeles, California, United States (Recruiting)
- Advent Health Orlando — Orlando, Florida, United States (Recruiting)
- Tampa General — Tampa, Florida, United States (Recruiting)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Ascension St. John Hospital — Detroit, Michigan, United States (Recruiting)
- Metropolitan Heart and Vascular Institute — Coon Rapids, Minnesota, United States (Recruiting)
- Providence St. Patrick Hospital — Missoula, Montana, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (Recruiting)
- Northwell Health/Lenox Hill Hospital — New York, New York, United States (Recruiting)
- Montefiore Medical Center - Moses — The Bronx, New York, United States (Recruiting)
- Novant Health New Hanover Regional Medical Center — Wilmington, North Carolina, United States (Recruiting)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (Recruiting)
- The Lindner Research Center at the Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Providence St. Vincent Medical Center — Portland, Oregon, United States (Recruiting)
- Legacy Research Institute (Legacy Emanuel Medical Center) — Portland, Oregon, United States (Recruiting)
- Oregon Health and Science System — Portland, Oregon, United States (Recruiting)
- UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical City Heart Hospital Dallas — Dallas, Texas, United States (Recruiting)
- Baylor University Medical Center — Dallas, Texas, United States (Recruiting)
- Memorial Herman Texas Medical Center — Houston, Texas, United States (Recruiting)
- The Heart Hospital Baylor Plano — Plano, Texas, United States (Recruiting)
- MultiCare Institute for Research Innovation — Puyallup, Washington, United States (Recruiting)
- Providence Sacred Heart Medical Center — Spokane, Washington, United States (Recruiting)
- Froedtert Hospital (Medical College of Wisconsin) — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Stacie Hallaway, Sr. Clinical Project Manager
- Email: shallawa@its.jnj.com
- Phone: 839-216-3087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.