Impella RP Flex for Right Ventricular Dysfunction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather real-world data on the Abiomed Impella RP Flex, a device that supports the heart's right side when it struggles to pump enough blood. The main goal is to evaluate the device's effectiveness outside a controlled lab setting. Individuals who have already received this device for right-side heart support are eligible to participate in the study. As a Phase 4 trial, this research seeks to understand how this FDA-approved and proven device benefits more patients in real-world settings.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that the Abiomed Impella RP Flex is safe for patients implanted with a right-sided ventricular assist device?
Research shows that using a right-sided heart pump, such as the Impella RP Flex, can be a safe option for patients with certain heart conditions. These devices assist the heart in pumping blood when the right side isn't functioning well. Studies have found that while right heart failure can occur after using a left-sided heart pump, a right-sided pump can help manage this issue.
One study found that these devices can successfully support patients until they receive a heart transplant, with success rates ranging from 9% to 69%. This indicates that many patients needing temporary heart support received the necessary assistance until transplantation.
Overall, despite some risks, the device has been used successfully in many cases. Discussing any concerns with a healthcare provider is important to understand the treatment's safety for a specific situation.12345Why are researchers excited about this trial?
The Impella RP Flex with Smart Assist is unique because it offers a right-sided ventricular assist device with advanced technology designed to support the heart more effectively. Unlike traditional treatments for right heart failure, which may include medications or other assist devices, this system provides real-time data and alerts to optimize patient management. Researchers are excited about its potential to improve patient outcomes by enhancing device performance and reducing complications through its smart assist features. This means better tailored support for the heart, which could lead to faster recovery times and improved quality of life for patients.
What evidence suggests that the Abiomed Impella RP Flex is effective for right-sided ventricular support?
This trial will evaluate the effectiveness of right-sided ventricular assist devices for patients with severe heart problems. Studies have shown that these devices can effectively support patients, with one study finding that 84.2% of patients survived for at least 30 days. Another study indicated that survival rates vary, with some patients living for several years after receiving the device. Although these devices don't always lead to long-term survival, they are often essential when the heart requires assistance. Research suggests that these devices can temporarily support heart function when needed.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are implanted with the Impella RP Flex device
Follow-up
Participants are monitored for survival and device performance post-implant
What Are the Treatments Tested in This Trial?
Interventions
- Impella RP Flex
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abiomed Inc.
Lead Sponsor
Citations
Outcome of right ventricular assist device implantation ...
Mortality reported at short-term as well at long-term was 19.66% (CI 15.73–23.59%) and 33.90% (CI 8.84–59.96%) in LVAD respectively versus 45.35% (CI 35.31–55.4 ...
Outcomes following isolated right ventricular assist device ...
The primary outcome was 2-year survival. Of 20,789 patients, 26 (0.13%) received iRVAD, 17 with pulsatile flow and 9 with continuous-flow ...
Evolution of Late Right Heart Failure With Left Ventricular ...
The purpose of this study was to determine the prevalence and severity of RHF over time and the association of RHF status at 3 months with 12-month outcomes ...
Preoperative predictors and outcomes of right ventricular ...
Right ventricular assist device implantation did not significantly affect eventual transplantation (P = .784) or longer-term survival (P = .870). Preoperative ...
Use of Right Ventricular Assist Device Post-Left ...
They found the 30-day survival rate was 84.2% and 66.7% for the pRVAD and sRVAD groups, respectively, but this difference was not significant [ ...
Temporary Right-Ventricular Assist Devices: A Systematic ...
Four studies [15,26,30,31] reported the rate of successful bridging to heart transplantation ranging between 9 % to 69%. Table 5. Outcome (other ...
Right heart failure after left ventricular assist device
Depending on the definition, 5–44% of people supported with an LVAD develop right heart failure (RHF), which is associated with worse outcomes.
The incidence, risk factors, and outcomes associated with ...
Early right-sided heart failure (RHF) after left ventricular assist device (LVAD) implantation is associated with increased mortality, ...
Right Heart Failure Following Left Ventricular Device ...
RHF at 1 or 3 months post-LVAD was a common and frequently transient condition, which, if resolved, was associated with relatively favorable prognosis.
Outcome after left ventricular assist device exchange
Patients with the HeartWare ventricular assist device as index device may be at higher risk of developing right heart failure and respiratory ...
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