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Clinical Trials/NCT05403372
NCT05403372Active, not recruitingNot Applicable

Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

InterShunt Technologies, Inc.1 site in 1 country10 target enrollmentStarted: May 7, 2022Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
10
Locations
1
Primary Endpoint
The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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.
  • •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.

Arms & Interventions

InterShunt PAS-C

Experimental

Intervention: PAS-C System (Device)

Outcomes

Primary Outcomes

The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.

Time Frame: 1 month

The proportion of subjects who experience a composite MACCE or systemic embolization event.

Secondary Outcomes

  • Echocardiogram evidence of interatrial shunt with left to right atrial flow(1 month)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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