SIRONA Trial Heart Failure NYHA Class III

Status Active, not recruiting

Clinical Trial Summary

This is a prospective, multi-center, open-label, single-arm feasibility trial to assess device safety and efficacy of the Cordella™ Heart Failure System in 10 NYHA Class III heart failure patients who will receive the Cordella™ Sensor implant.

Clinical Trial Description

The objectives of this study are to establish that the Cordella™ Sensor can be safely delivered, deployed, and remain stable within the target pulmonary artery (PA) segment through 30 days post-implant as well as to measure the accuracy of Cordella™ Sensor PA pressure measurements compared with fluid-filled catheter PA pressure measurements obtained by standard right heart catheterization (RHC) at 90 days post implant. Safety measures will include the frequency and rates of adverse events, both overall and for each specific event, which will be collected throughout the study. Subjects will remain in this trial for 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03375710
Study type	Interventional
Source	Endotronix, Inc.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	December 1, 2017
Completion date	February 28, 2029

View Details

See also
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