RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05

Study Completion:2031-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06859970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Los Robles Health System

Thousand Oaks, California, 91360

United States

Christ Hospital

Cincinnati, Ohio, 45219

United States

Methodist Healthcare

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: InterShunt Technologies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05

Study Completion Date2031-09

Study Record Updates

Study Start Date2025-05

Study Completion Date2031-09

Terms related to this study

Additional Relevant MeSH Terms

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