🏛️ Verified NIH Record • Updated 2026-05-26
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure (NCT06859970)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: InterShunt Technologies, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Bernard's Healthcare — Jonesboro, Arkansas
Age range: 40 Years to 85 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- St. Bernard's Healthcare — Jonesboro, Arkansas
- Los Robles Health System — Thousand Oaks, California
- Ascension St. Vincent Hospital — Indianapolis, Indiana
- Christ Hospital — Cincinnati, Ohio
- The Ohio State University — Columbus, Ohio
- Methodist Healthcare — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Heart Failure
- REDUCE LAP-HFREF TRIAL — New York, New York
- Physiological Effects Ketone Ester in Heart — Cleveland, Ohio
- DASH Diet in Heart Failure Outpatients — Sacramento, California
- Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients — Huntsville, Alabama
- LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System. — Birmingham, Alabama
- A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation — Alexander City, Alabama
Explore by condition: All Heart Failure clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.