Revivent TC System for Heart Failure

Recruiting in Palo Alto (17 mi)

+30 other locations

Overseen ByAndrew S Wechsler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: BioVentrix

No Placebo Group

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.

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

My heart has a scar in specific areas and I am referred for surgery.

My heart failure symptoms are severe and not improving with medication.

I am 18 years old or older.

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.

I do not have another serious illness that could cause death within a year, nor do I have cancer that is not in remission.

I have had or am waiting for an organ transplant (not heart).

My kidney function is low with high creatinine or low GFR.

I have not had a stroke, brain bleed, or serious brain condition in the last 6 months.

I have a blood clot or mass in my heart that hasn't been treated with blood thinners.

My heart valve leak is more than moderate due to a functional issue or muscle rupture.

My heart's pulmonary artery pressure is high, or I have cor pulmonale.

I've had surgery or radiation on my right neck that may affect catheter placement.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Revivent TC System

Group II: Control PoolActive Control1 Intervention

Treatment with Guideline Directed Medical Therapy for Heart Failure Symptoms Only