CompletedNot Applicable

Acute Assessment of the Aria CV System in Patients With WHO Groups 2 and 3 Pulmonary Hypertension

Austria18 participantsStarted 2021-07-12

Plain-language summary

This study is a prospective, non-randomized, two arm, single-center acute feasibility study assessing safety and performance of the Aria CV Acute PH System in WHO Group 2 and 3 PH patients.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years or older
✓. Symptomatic WHO Functional Class (FC) III
✓. Based on preexisting echocardiography within the past 6 months, evidence of right heart dysfunction: RV ejection fraction (RVEF) \< 45% by visual estimate, and at least one of the following:
✓. Tricuspid Annulus Plane Systolic Excursion (TAPSE) ≤16 mm
✓. RV Fractional area change \<35%
✓. RVs' velocity \< 10 cm/s
✓. RV free wall strain \<18%
✓. RVEF \< 35% by visual estimate

Exclusion criteria

✕. Anatomy not suitable for RHC
✕. Anatomy not suitable for placement of Aria CV Acute Device:
✕. Contraindication to 16 Fr femoral vein access
✕. Body habitus that would preclude safe placement of any components of Aria CV Acute Device
✕. Any previous tricuspid valvular surgery, percutaneous valve repair, or presence of prosthetic cardiac device such as pacemaker or defibrillator leads, or vena cava filter that in the opinion of the investigator may interfere with investigational device placement or performance
✕. Uncontrolled atrial fibrillation
✕. Sustained tachyarrhythmia (heart rate \>110/min) at time of index procedure
✕. Right heart valve regurgitation:

What they're measuring

Primary Safety Endpoint

Timeframe: 30 Days

Trial details

NCT IDNCT05001711

SponsorAria CV, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-30

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