Clinical Trials Logo

Clinical Trial Summary

This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.

Clinical Trial Description

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary hypertension (PH). The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient and to evaluate its performance in treating patients with PH and right heart dysfunction. The study will be conducted in a maximum of 20 centers in the United States and up to 30 patients will receive implants. Patients will be evaluated at each of the following time intervals: pre-operative, implant procedure, 7-day (or discharge if earlier), and 1-, 2-, 3-, 4-, 6-, 9-, 12-, 15-, 18-, 21-, and 24-months post index procedure. The Aria CV PH System will be assessed at each follow-up visit. The duration of the study is anticipated to last about 2 years for each patient. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04555161
Study type Interventional
Source Aria CV, Inc
Contact Caytie Longhenry
Phone 651-200-4891
Status Recruiting
Phase N/A
Start date March 15, 2021
Completion date October 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT01950585 - Hydroxyurea in Pulmonary Arterial Hypertension Early Phase 1
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Recruiting NCT04554160 - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Enrolling by invitation NCT03683186 - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension Phase 3
Completed NCT01894035 - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Not yet recruiting NCT04083729 - Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy N/A
Terminated NCT02243111 - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound N/A
Completed NCT02216279 - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension Phase 2
Completed NCT02821156 - Study on the Use of Inhaled NO (iNO) N/A
Terminated NCT02246348 - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc) N/A
Recruiting NCT01913847 - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension Phase 3
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT06240871 - Contrast Enhanced PA Pressure Measurements
Completed NCT02377934 - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Recruiting NCT01091012 - Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension Phase 3
Completed NCT02275793 - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Completed NCT00739375 - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension. Phase 1
Completed NCT01484899 - Smoking: a Risk Factor for Pulmonary Arterial Hypertension? N/A
Completed NCT01463514 - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension N/A