Revivent TC System for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Revivent TC System, a new device for treating heart failure. Researchers aim to evaluate its effectiveness in people with heart failure who have specific conditions, such as a scar or weak spot in the heart's left side. Participants will either receive the new device or continue with standard treatment. Those whose heart failure symptoms do not improve with medication and have a known heart scar might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future heart failure treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must be on adequate Guideline Directed Medical Therapy (GDMT) to participate.
What prior data suggests that the Revivent TC System is safe for heart failure patients?
Research has shown that the Revivent TC System has been tested for safety in people with heart failure. One study found that the system safely reduced the size of an enlarged heart chamber, though it did not improve overall heart function. Another study examined serious side effects six months after treatment and monitored changes in heart pumping efficiency.
Safety data compared results with traditional heart surgeries, suggesting the Revivent TC System might offer a less invasive option. Additionally, a review of multiple studies found that this system can be used safely in patients with certain heart conditions.
Overall, these findings suggest that the Revivent TC System is generally well-tolerated, with no major safety concerns reported in these studies.12345Why are researchers excited about this trial?
The Revivent TC System is unique because it offers a new approach to treating heart failure by directly addressing the structural issues in the heart. Unlike standard treatments that focus on managing symptoms with medication, the Revivent TC System is a minimally invasive device that reshapes the heart to improve its function. This method can potentially provide long-term benefits and reduce the need for heart failure medications. Researchers are excited about this treatment because it targets the root cause of heart failure, offering hope for improved quality of life and outcomes for patients.
What evidence suggests that the Revivent TC System is effective for heart failure?
Research has shown that the Revivent TC System, which participants in this trial may receive, can aid individuals with heart failure by reducing the size of the left side of the heart. Studies have found it decreased heart size by 40% and enhanced heart function. Patients experienced less difficulty with mitral regurgitation, and their hearts operated more efficiently. Those who received the treatment reported improved well-being and quality of life. However, one study found that although the device altered heart size, it did not enhance overall heart failure outcomes.14678
Who Is on the Research Team?
Andrew S Wechsler, MD
Principal Investigator
Drexel University College of Medicine
Gregg W Stone, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Jerry D Estep, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 with heart failure symptoms not improved by medication, left ventricular ejection fraction under 45%, and specific types of LV aneurysm or scar. They must be on standard heart failure therapy, able to do a walk test and questionnaire, not pregnant nor planning pregnancy within a year, and without severe arrhythmias or other major health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive treatment with the Revivent TC System or are maintained on Guideline Directed Medical Therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Revivent TC
Trial Overview
The BioVentrix Revivent TC System is being tested in this study against active control. The trial will enroll 126 patients; two-thirds will receive the device treatment while one-third are controls. It's designed to see how well the device helps improve heart function compared to current treatments.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Treatment with the Revivent TC System
Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioVentrix
Lead Sponsor
Published Research Related to This Trial
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 ...
The Prospective ALIVE Trial | JACC: Heart Failure
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 ...
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 Revivent TC™ System Clinical Study
Composite primary effectiveness endpoint consisting of: No hospital readmission for new or worsening heart failure, and; Improvement in MLHF Quality of Life ...
Transcatheter left ventriculoplasty - PMC - PubMed Central
Preliminary results showed a 40% reduction in LV systolic and diastolic volumes, reduction in mitral regurgitation, and improvements in LVEF, NYHA class and ...
Clinical Study of the BioVentrix Revivent TC for ...
Secondary Safety Endpoint, Rate of Serious Adverse Device Effects, 6 months ; Secondary Efficacy Endpoint, Change in Left Ventricular Ejection Fraction compared ...
Less Invasive Ventricular Enhancement™ Revivent TC
This patient booklet is for those who have suffered a heart attack resulting in damage to the left side of the heart causing it to scar.
(PDF) Safety and efficacy of less-invasive ventricular ...
Our paper represents the first systematic approach to investigate the efficacy and safety of LIVE procedure using Revivent TCTM anchor system ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.