An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
NCT ID: NCT06859970
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-05-15
2031-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PAS-C System
The PAS-C System is a catheter designed to remove a small section of septal tissue in the interatrial septum to treat heart failure patients without the need for a permanent implant.
PAS-C System
All patients will undergo catheterization with the PAS-C System to create an interatrial shunt to reduce left atrial pressure in the heart.
Interventions
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PAS-C System
All patients will undergo catheterization with the PAS-C System to create an interatrial shunt to reduce left atrial pressure in the heart.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
40 Years
85 Years
ALL
No
Sponsors
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InterShunt Technologies, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PTCL-00007
Identifier Type: -
Identifier Source: org_study_id
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