MedTrace Logo

An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

NCT06859970 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-26

No results posted yet for this 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

  • Heart Failure
  • Heart Failure NYHA Class III
  • Heart Failure With Reduced Ejection Fraction
  • Ambulatory Heart Failure, NYHA Class IV

Interventions

DEVICE

PAS-C System

All patients will undergo catheterization with the PAS-C System to create an interatrial shunt to reduce left atrial pressure in the heart.

Sponsors & Collaborators

  • InterShunt Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2026-06-30
Completion
2031-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06859970 on ClinicalTrials.gov