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

NCT06859970 | Recruiting DMC FDA Device

• 1 other identifier: PTCL-00007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (1)

• Measure of major safety events in the periprocedural timeframe

  Proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization

  Through one month post procedure

Study Arms (1)

PAS-C System

EXPERIMENTAL

The PAS-C System is a catheter designed to remove a small section of septal tissue in the interatrial septum to treat heart failure patients without the need for a permanent implant.

Device: PAS-C System

Interventions

PAS-C System DEVICE

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

PAS-C System

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
• At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months.
• Receiving maximally tolerated guideline directed medical therapy for Heart Failure management.
• LVEF ≥ 20% and ≤ 40% according to baseline echocardiography.
• Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InterShunt Technologies, Inc.: lead

Study Sites (6)

St. Bernard's Healthcare

Jonesboro, Arkansas, 72401, United States

RECRUITING

Los Robles Health System

Thousand Oaks, California, 91360, United States

RECRUITING

Ascension St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Methodist Healthcare

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lisa Ingham

CONTACT

612-242-2226; lingham@intershunt.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2031
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)