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

Launched by INTERSHUNT TECHNOLOGIES, INC. · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device designed to improve symptoms in patients with heart failure. The device creates a small opening between the two upper chambers of the heart, which may help relieve pressure and improve blood flow. The main goal of this early study is to see if the device is safe for use in patients who have heart failure symptoms and to gather information that could help refine its design for future studies.

To be eligible for the trial, participants should have a history of heart failure, classified as either NYHA Class II, III, or ambulatory Class IV, and must be receiving the best possible medical treatment for their condition. Key requirements include having a specific range of heart function as measured by an echocardiogram and evidence of elevated pressure in the heart. If you or a loved one meet these criteria, you could potentially participate in this study. However, there are certain health conditions that would exclude someone from participating, such as recent heart surgery or severe heart failure. Participants will be closely monitored throughout the trial to ensure their safety and to see how well the device works.

Gender

ALL

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.