Back to resultsEvaluation of an Implant Free Interatrial Shunt to Improve Heart Failure (EASE HF)
Primary Purpose
Heart Failure
Status
Active
Phase
Not Applicable
Locations
Georgia
Study Type
Interventional
Intervention
PAS-C System
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Key Inclusion Criteria:
- Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy.
- At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP.
- LVEF ≥ 40%.
- Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography:
- Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure.
Key Exclusion Criteria:
- Stroke or thromboembolic event in the past 6 months.
- Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD > 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
- Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
- More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
- Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
- BMI > 40.
- 6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test.
- Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate > 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline).
- Evidence of precapillary pulmonary hypertension defined as PVR > 2 Wood units at rest, TPG > 15 at rest or with exercise, resting RA > 15 mmHg, or RA to PCWP ratio > 0.7 at rest and with exercise.
- Anatomic anomaly that precludes creation of interatrial shunt.
Sites / Locations
- Tbilisi Heart and Vascular Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
InterShunt PAS-C
Arm Description
Outcomes
Primary Outcome Measures
The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
The proportion of subjects who experience a composite MACCE or systemic embolization event.
Secondary Outcome Measures
Echocardiogram evidence of interatrial shunt with left to right atrial flow
Proportion of subjects with visible shunt demonstrating left to right atrial flow as determined by echocardiographer
Full Information
NCT ID
NCT05403372
First Posted
May 24, 2022
Last Updated
February 28, 2023
Sponsor
InterShunt Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05403372
Brief Title
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Acronym
EASE HF
Official Title
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 7, 2022 (Actual)
Primary Completion Date
August 6, 2022 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InterShunt Technologies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
InterShunt PAS-C
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PAS-C System
Intervention Description
The InterShunt PAS-C System is a transcatheter system that creates a shunt by excising tissue from the interatrial septum resulting in a left to right atrial shunt that off-loads elevated left atrial pressure, potentially reducing symptoms and improving quality of life. The PAS-C System does not require a permanent implant to maintain patency of the interatrial shunt.
Primary Outcome Measure Information:
Title
The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
Description
The proportion of subjects who experience a composite MACCE or systemic embolization event.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Echocardiogram evidence of interatrial shunt with left to right atrial flow
Description
Proportion of subjects with visible shunt demonstrating left to right atrial flow as determined by echocardiographer
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy.
At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP.
LVEF ≥ 40%.
Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography:
Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure.
Key Exclusion Criteria:
Stroke or thromboembolic event in the past 6 months.
Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD > 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
BMI > 40.
6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test.
Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate > 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline).
Evidence of precapillary pulmonary hypertension defined as PVR > 2 Wood units at rest, TPG > 15 at rest or with exercise, resting RA > 15 mmHg, or RA to PCWP ratio > 0.7 at rest and with exercise.
Anatomic anomaly that precludes creation of interatrial shunt.
Facility Information:
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
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