Revivent TC System for Heart Failure

Not currently recruiting at 31 trial locations

Overseen By Noel Messenger, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioVentrix

Must be taking: Guideline directed medical therapy

Disqualifiers: Valvular disease, Mitral regurgitation, Coronary revascularization, Pulmonary pressure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 month

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

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

Your heart's left ventricle is too big when it squeezes.

Subject or a legally authorized representative must provide written informed consent

Agree to required follow-up visits

Exclusion Criteria

I cannot take blood thinners due to health reasons or other issues.

I have had open heart surgery or significant inflammation of the heart lining.

If you had a certain type of heart treatment within the past 60 days, you cannot join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the Revivent TC System or are maintained on Guideline Directed Medical Therapy

1 month

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?

Group I: Treatment Experimental Treatment 1 Intervention

Treatment with the Revivent TC System

Group II: Control Pool Active Control 1 Intervention

Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only

Who Is Running the Clinical Trial?

BioVentrix

Lead Sponsor

Trials

8

Recruited

510+

Published Research Related to This Trial

The Revivent TC™ system is designed to treat heart failure caused by previous heart attacks by reshaping the left ventricle using microanchors to exclude scarred heart tissue.

This innovative procedure, known as Less Invasive Ventricular Enhancement, requires close teamwork between cardiac surgeons and interventional cardiologists to achieve optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal access left ventricular reconstruction. Pillay, T., Neves, P., Benetti, F., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39797846/

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 ...

2. jacc.org jacc.org/doi/abs/10.1016/j.jchf.2024.09.023

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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2474870622018711

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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02931240

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10113960/

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02553785

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 ...

7. bioventrix.com bioventrix.com/wp-content/uploads/2022/11/bioventrix-patient-booklet-eng.pdf

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.

8. researchgate.net researchgate.net/publication/352866070_Safety_and_efficacy_of_less-invasive_ventricular_enhancement_procedure_with_the_transcatheter_Revivent_TC_system_in_patients_with_left_ventricular_aneurysm_a_systematic_review

(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 ...