Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

NCT05403372 | Unknown

• 1 other identifier: 21-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (1)

• Echocardiogram evidence of interatrial shunt with left to right atrial flow

  1 month

Study Arms (1)

InterShunt PAS-C

EXPERIMENTAL

Device: PAS-C System

Interventions

PAS-C System DEVICE

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.

InterShunt PAS-C

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• InterShunt Technologies, Inc.: lead

Study Sites (1)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: May 7, 2022
• Primary Completion: August 6, 2022
• Study Completion: August 1, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)