Clinical trial NCT05403372: Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Official title: Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: InterShunt Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-03
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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: 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.

Primary outcomes:
measure: The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
timeFrame: 1 month
Secondary outcomes:
measure: Echocardiogram evidence of interatrial shunt with left to right atrial flow
timeFrame: 1 month
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
Study officials:
References: