An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

Running, not enrolling · Not applicable

Conditions studied: Heart Failure, Heart Failure NYHA Class III, Heart Failure With Reduced Ejection Fraction, Ambulatory Heart Failure, NYHA Class IV

In brief

The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.

Key facts

Study ID

NCT06859970

Run by

InterShunt Technologies, Inc.

People needed

20

Starts

2025-05-15

Expected to finish

2031-09-01

Last updated by the study team

2026-05-27

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
• At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months.
• Receiving maximally tolerated guideline directed medical therapy for Heart Failure management.
• LVEF ≥ 20% and ≤ 40% according to baseline echocardiography.
• Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure.

You may not qualify if…

• Any of the following within the prior 6 months: Stroke, thromboembolism, severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 1.8 L/min/m2, LVEDD > 8 cm, or received inotropic therapy for LVEF less than 20%.
• Any of the following within the prior 3 months: Myocardial infarction percutaneous cardiac intervention, CABG, on cardiac transplant list, cardiac resynchronization therapy implant, AICD implant, or indicated for coronary revascularization at the time of enrollment.
• Transseptal procedure or percutaneous cardiac intervention planned within the next 6 months.
• Chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease.
• Patent foramen ovale (PFO) device or atrial septal defect (ASD) device.
• BMI > 40.
• Anatomic anomaly that precludes creation of interatrial shunt.

Where it is running

• St. Bernard's Healthcare — Jonesboro, Arkansas, United States
• Los Robles Health System — Thousand Oaks, California, United States
• Ascension St. Vincent Hospital — Indianapolis, Indiana, United States
• Christ Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Methodist Healthcare — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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