Right Ventricular (RV) DysfunctionNCT06637644
Impella RP Flex with Smart Assist
An observational study of Right Ventricular (RV) Dysfunction, run by Abiomed Inc. at 31 sites in United States.
Trial summary
To capture observational data of the Abiomed Impella RP Flex in a real-world setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Right Ventricular (RV) Dysfunction
- What is being tested?
- Right-sided ventricular assist device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 31 sitesUnited States
- Study dates
- 29 May 2024to 1 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study includes sites from the US
Who may be able to join
- Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.
Who cannot join
- None
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites, 31 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
The Lindner Research Center at the Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
Metropolitan Heart and Vascular Institute
Coon Rapids, Minnesota, 55433
- Recruiting
Medical City Heart Hospital Dallas
Dallas, Texas, 75243
- Recruiting
Baylor University Medical Center
Dallas, Texas, 75246
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
- Recruiting
Ascension St. John Hospital
Detroit, Michigan, 48236
- Recruiting
Memorial Herman Texas Medical Center
Houston, Texas, 77030
- Recruiting
Baptist Health Heart Failure and Transplant Institute
Little Rock, Arkansas, 72205
- Recruiting
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
- Recruiting
University of Southern California (Keck USC)
Los Angeles, California, 90033
- Recruiting
Froedtert Hospital (Medical College of Wisconsin)
Milwaukee, Wisconsin, 53226
- Recruiting
Providence St. Patrick Hospital
Missoula, Montana, 59802
- Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
- Recruiting
Northwell Health/Lenox Hill Hospital
New York, New York, 10075
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
Advent Health Orlando
Orlando, Florida, 32803
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
- Recruiting
The Heart Hospital Baylor Plano
Plano, Texas, 75093
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
- Recruiting
Legacy Research Institute (Legacy Emanuel Medical Center)
Portland, Oregon, 97232
- Recruiting
Oregon Health and Science System
Portland, Oregon, 97239
- Recruiting
MultiCare Institute for Research Innovation
Puyallup, Washington, 98372
- Recruiting
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
- Recruiting
Tampa General
Tampa, Florida, 33606
- Recruiting
Montefiore Medical Center - Moses
The Bronx, New York, 10467
- Recruiting
Pima Heart and Vascular
Tucson, Arizona, 85718
- Recruiting
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
- Recruiting
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
About this study
Official title: Impella RP Flex Registry
To capture observational data of the Abiomed Impella RP Flex in a real-world setting.
- Conditions
- Right Ventricular (RV) Dysfunction
- Being tested
- Right-sided ventricular assist device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right-sided ventricular assist deviceDevice
Percutaneous device for right heart support
| Study group | Role | What they receive |
|---|---|---|
| Patients implanted with right-sided ventricular assist device | Not described Receives: Device: Right-sided ventricular assist device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectives
Survival at hospital discharge, with follow-ups at 30 days, 90 days, and 1-year post-discharge of Impella RP patients from real-world surveillance data.
Measured: 1 year post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start29 May 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular (RV) DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637644
- Sponsor's protocol ID
- Impella RP Flex Study
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impella RP Flex Registry
- ClinicalTrials.gov ID
- NCT06637644
- Acronym / sponsor ID
- Impella RP Flex Study
- Conditions
- Right Ventricular (RV) Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To capture observational data of the Abiomed Impella RP Flex in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with right-sided ventricular assist device | – | Device: Right-sided ventricular assist device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study includes sites from the US
Key inclusion criteria (1 listed)
- Subjects who received mechanical circulatory support (MCS) with an Impella RP Flex will be considered eligible for the registry.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right-sided ventricular assist devicePercutaneous device for right heart support | Device | Patients implanted with right-sided ventricular assist device |
Primary outcome
Objectives
Time frame: 1 year post implant
Survival at hospital discharge, with follow-ups at 30 days, 90 days, and 1-year post-discharge of Impella RP patients from real-world surveillance data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular (RV) Dysfunction, run by Abiomed Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stacie Hallaway, Sr. Clinical Project Manager (839-216-3087, shallawa@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectives (time frame: 1 year post implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.