Revivent System for Congestive Heart Failure
(RELIVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment for people with congestive heart failure. It compares standard medical care with a new method called the Revivent System, which aims to improve heart function by reducing scarred areas. The trial seeks individuals whose heart failure symptoms have not improved with medicine alone and who have specific heart damage visible on imaging tests. Participants will either receive the new treatment or continue with standard care, and researchers will monitor their progress over a year.
As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to better treatments for heart failure.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it requires that you are on adequate Guideline Directed Medical Therapy (GDMT). It's best to discuss your current medications with the trial team.
What prior data suggests that the Revivent System is safe for treating congestive heart failure?
Research has shown that the Revivent System is generally safe for people with heart failure. Studies have found that this system can help reduce the size of the left side of the heart, a common issue for heart failure patients with damaged heart tissue. In these studies, patients did not need to return to the hospital for new or worsening heart failure after receiving the treatment. They also experienced improvements in quality of life and physical abilities, as demonstrated in a walking test.
While the Revivent System did not lead to major improvements in some medical results, it remains safe to use. This indicates that even though the treatment might not resolve all heart failure issues, it does not appear to introduce new safety concerns. Overall, evidence supports that the Revivent System is well-tolerated by patients.12345Why are researchers excited about this trial's treatment for heart failure?
The Revivent System is unique because it offers a new approach to treating congestive heart failure by directly targeting the damaged areas of the heart. Unlike standard treatments that typically involve medications to manage symptoms, the Revivent System involves a minimally invasive surgery called a mini thoracotomy. During this procedure, special anchors are used to reshape the heart, specifically reducing the size of the left ventricle and improving its function. This innovative method could lead to better heart mechanics and potentially improve quality of life for patients. Researchers are excited about this approach because it directly addresses the structural issues of the heart, which could offer more lasting and effective relief compared to traditional medication-based therapies.
What evidence suggests that the Revivent System is effective for congestive heart failure?
In this trial, participants will receive either the Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT) or GDMT alone. Research has shown that the Revivent System can help shrink the left ventricle, an important part of the heart, in people with heart failure. Specifically, studies found that all patients experienced a noticeable and lasting decrease in the size of this heart chamber, which is a positive sign for heart health. Additionally, patients' heart pumping ability improved by 16%. None of the patients returned to the hospital for new or worsening heart failure. The studies also noted improvements in quality of life and physical abilities, such as better performance on a walking test.12346
Who Is on the Research Team?
Vinod THourani, MD
Principal Investigator
Piedmont Healthcare
Marat Fudim, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for people with heart failure symptoms not improved by medication, a left ventricular ejection fraction below 40%, and specific types of scars in the heart. Participants must have completed certain health questionnaires, be on standard heart failure meds, consent to the study's terms, and agree to follow-up visits.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT) or GDMT alone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Revivent System
Trial Overview
The RELIVE trial is testing if adding the Revivent System to usual heart failure medications (GDMT) helps more than GDMT alone. It's a study where two-thirds of patients get the new treatment and one-third don't. They'll check safety after 30 days and how well it works after 6 months and a year.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Medical Intervention through a mini thoracotomy, placement of anchors to plicate the scarred areas of the heart thereby reducing the left ventricle size and improving left ventricle mechanics. Subjects would continue on Guideline Directed Medical Therapy (GDMT)
Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioVentrix
Lead Sponsor
Citations
The Prospective ALIVE Trial
Conclusions: The Revivent TC® system safely reduced LV dimensions in HF patients caused by extensive anterior scar but did not improve clinical effectiveness ...
One-Year Outcomes Published for BioVentrix's Revivent ...
100% of patients demonstrated a significant and sustained reduction in LV volumes · 16% improvement in LV ejection fraction (29 ± 8% vs 34 ± 9%; ...
BioVentrix Revivent TC™ System Clinical Study
No hospital readmission for new or worsening heart failure, and · Improvement in MLHF Quality of Life score by >10 points, and · Improvement in 6 Minute Walk ...
Midterm Outcome of Hybrid Transcatheter and Minimally ...
Hybrid LVR for symptomatic HF after AMI is safe and results in significant improvement in EF, reduction in LV volumes, and sustained improvement in symptoms.
BioVentrix® Announces First Patient Treated with Revivent ...
The trial aims to evaluate the safety and efficacy of the Revivent System in restoring left ventricular function in heart failure patients with ...
Transcatheter Left Ventricular Reconstruction in Heart ...
The Revivent TC system safely reduced LV dimensions in HF patients caused by extensive anterior scar but did not improve clinical effectiveness outcomes at 1 ...
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