Revivent TC System for Heart Failure

Recruiting at 30 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

126 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, multi-center, dual-arm pivotal study of the BioVentrix Revivent TC System, with 2:1 study vs. active concurrent control group allocation ratio. This study will include 126 patients of which 84 patients will be treated with the investigational device and 42 patients will be included in an active control group.

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.

How is the Revivent TC treatment different from other heart failure treatments?

The Revivent TC System is unique because it offers a less invasive approach to reshape and reduce the size of the left ventricle in patients with heart failure due to previous heart attacks. It uses micro-anchor pairs to exclude scarred heart tissue, which helps improve heart function without the need for open-heart surgery. ^{1 2 3 4 5}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

First Successful LVAD Implantation After BioVentrix Revivent TC Ventricular Reshaping. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Patient selection for LIVE therapy: From clinical indications to multimodality imaging individual case planning. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Less invasive ventricular reconstruction for ischaemic heart failure. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Catheter ablation of frequent ventricular tachycardia after interventional left ventricular restoration with the Revivent-Transcatheter(™)-system. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Minimal access left ventricular reconstruction. [2021]