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NCT06859970

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

Active, Not Recruiting
NAAges 40–85InterventionalTreatment
InterShunt Technologies, Inc.
~20 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:PAS-C System

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure of major safety events in the periprocedural timeframe
Measured over Through one month post procedure

Conditions

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

Explore related trials

Heart Failure

NCT06859970

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ascension St. Vincent Hospital

    Indianapolis, Indianano site contact published

  • Christ Hospital

    Cincinnati, Ohiono site contact published

  • Los Robles Health System

    Thousand Oaks, Californiano site contact published

  • Methodist Healthcare

    San Antonio, Texasno site contact published

  • St. Bernard's Healthcare

    Jonesboro, Arkansasno site contact published

  • The Ohio State University

    Columbus, Ohiono site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Measure of major safety events in the periprocedural timeframeThrough one month post procedure

    Proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization