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An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
NCT06859970 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE PAS-C System
Study Locations (6)
Ohio
- Christ Hospital — Cincinnati
- The Ohio State University — Columbus
Arkansas
- St. Bernard's Healthcare — Jonesboro
California
- Los Robles Health System — Thousand Oaks
Indiana
- Ascension St. Vincent Hospital — Indianapolis
Texas
- Methodist Healthcare — San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-05-15 |
| Est. Completion | 2031-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06859970
The ClinicalTrials.gov registry entry for NCT06859970 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InterShunt Technologies, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention — of which PAS-C System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06859970 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Ohio, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06859970 about?
NCT06859970 is a clinical study titled "An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure". 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 b...
What is the current status of trial NCT06859970?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-05-15. Estimated completion is 2031-09.
What conditions does trial NCT06859970 study?
This clinical trial studies the following conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure NYHA Class III, Ambulatory Heart Failure, NYHA Class IV. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06859970?
The interventions under investigation include: PAS-C System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06859970?
This trial is sponsored by InterShunt Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06859970 being conducted?
This trial has 6 study locations across Arkansas, California, Indiana, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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