An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure (NCT06859970)
🩺 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: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).
Location: St. Bernard's Healthcare — Jonesboro, Arkansas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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.