Status:
UNKNOWN
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Lead Sponsor:
InterShunt Technologies, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
40-85 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
May 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05403372
Start Date
May 7 2022
End Date
August 1 2023
Last Update
March 1 2023
Active Locations (1)
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1
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia