Evaluation of a device to improve heart failure symptoms without implants

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

This study is testing a new device that helps relieve heart failure symptoms by creating a small opening in the heart to see if it can be safely used in patients with heart failure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: InterShunt Technologies, Inc. (industry)
• Locations: 6 sites (Jonesboro, Arkansas and 5 other locations)
• Trial ID: NCT06859970 on ClinicalTrials.gov

What this trial studies

This early feasibility study aims to assess the safety and feasibility of the InterShunt PAS-C System, which creates an interatrial shunt by removing septal tissue to lower left atrial pressure in patients with heart failure. The study will enroll 20 subjects with documented heart failure symptoms and evaluate the occurrence of major adverse cardiac events within one month post-procedure. The findings will help refine patient selection and device design for future studies.

Who should consider this trial

Good fit: Ideal candidates include individuals with NYHA Class II to ambulatory Class IV heart failure and a documented history of heart failure for at least six months.

Not a fit: Patients with severe or advanced heart failure, such as Stage D heart failure, or those who are non-ambulatory may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly alleviate heart failure symptoms and improve quality of life for patients.

How similar studies have performed: While this approach is novel, similar studies targeting heart failure symptom relief through innovative methods have shown promise.

Eligibility criteria

Inclusion Criteria:

* 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.

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.

Where this trial is running

Jonesboro, Arkansas and 5 other locations

• St. Bernard's Healthcare — Jonesboro, Arkansas, United States (RECRUITING)
• Los Robles Health System — Thousand Oaks, California, United States (RECRUITING)
• Ascension St. Vincent Hospital — Indianapolis, Indiana, United States (RECRUITING)
• Christ Hospital — Cincinnati, Ohio, United States (RECRUITING)
• The Ohio State University — Columbus, Ohio, United States (RECRUITING)
• Methodist Healthcare — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Lisa Ingham

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