A-FLUX Reducer for Microvascular Angina

(SERRA-I US Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VahatiCor, Inc.

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

VahatiCor's Coronary Sinus Reducer (A-FLUX) has been designed to improve angina or angina-like symptoms in patients with CMD. SERRA-I is an early feasibility study that evaluates the safety and clinical performance of the A-FLUX Reducer in this population.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have ongoing chest pain or similar symptoms from coronary microvascular dysfunction, despite taking at least two heart medications. Their heart function must be moderately preserved (LVEF ≥25%), and they need to meet certain test results and be willing to follow up.

Inclusion Criteria

I have had ongoing heart symptoms for over 30 days despite best treatment.

CFR less than 2.5 measured with continuous thermodilution within 30 days of index procedure

Willing and able to sign informed consent

Exclusion Criteria

I have other health problems that may limit my life expectancy to less than one year.

I am currently in the hospital for confirmed or suspected COVID-19.

Pregnant or planning pregnancy within the next 12 months

What Are the Treatments Tested in This Trial?

Interventions

• A-FLUX Reducer System

Trial Overview

The study is testing the A-FLUX Reducer System, a device placed in the heart's veins to help reduce angina symptoms in people with coronary microvascular dysfunction. This early-stage trial focuses on safety and how well the device works.

How Is the Trial Designed?

Group I: Device: A-FLUX Reducer System Experimental Treatment 1 Intervention

Treatment

Who Is Running the Clinical Trial?

VahatiCor, Inc.

Lead Sponsor