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NCT06859970 · ClinicalTrials.gov registry record · NA
An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
A NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by InterShunt Technologies.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 6
- Study locations
NCT06859970: Recruiting NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by InterShunt Technologies.
NCT06859970 is a NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction that is actively recruiting participants, run by InterShunt Technologies. The registered enrollment target is 20 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06859970, a NA study of Heart Failure and Heart Failure With Reduced Ejection Fraction, is actively recruiting participants, sponsored by InterShunt Technologies.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization
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 |
What NCT06859970 shows while recruiting
NCT06859970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).
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.
NCT06859970 lists 6 locations in 5 states (Ohio, Arkansas, California).
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.
What interventions are being tested in trial NCT06859970?
The interventions under investigation include: PAS-C System (DEVICE).
Who is sponsoring clinical trial NCT06859970?
This trial is sponsored by InterShunt Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06859970's enrollment target sits among peer trials
20 350th of 397 higher than 37 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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