Actively Recruiting
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Led by InterShunt Technologies, Inc. · Updated on 2025-09-26
20
Participants Needed
6
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 heart failure for at least 6 months before screening
- At least one hospitalization for heart failure, or treatment with intravenous diuretics for heart failure, or elevated BNP in the past 12 months
- Receiving maximally tolerated guideline-directed medical therapy for heart failure management
- Left ventricular ejection fraction between 20% and 40% based on baseline echocardiography
- Resting right heart catheterization showing elevated pulmonary capillary wedge pressure compared to right atrial pressure
You will not qualify if you...
- Stroke, thromboembolism, severe or advanced heart failure such as Stage D, non-ambulatory NYHA Class IV, cardiac index less than 1.8 L/min/m2, left ventricular end-diastolic diameter greater than 8 cm, or inotropic therapy for LVEF less than 20% within the prior 6 months
- Myocardial infarction, percutaneous cardiac intervention, coronary artery bypass graft, cardiac transplant listing, cardiac resynchronization therapy implant, AICD implant, or indicated for coronary revascularization within the prior 3 months
- Planned transseptal procedure or percutaneous cardiac intervention within the next 6 months
- Chronic pulmonary disease requiring continuous home oxygen or hospitalization for pulmonary disease within the prior 12 months
- Presence of patent foramen ovale device or atrial septal defect device
- Body mass index over 40
- Anatomic abnormality preventing creation of interatrial shunt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
St. Bernard's Healthcare
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
Los Robles Health System
Thousand Oaks, California, United States, 91360
Actively Recruiting
3
Ascension St. Vincent Hospital
Indianapolis, Indiana, United States, 46260
Actively Recruiting
4
Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
5
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Methodist Healthcare
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
L
Lisa Ingham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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