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ACTIVE NOT RECRUITING
NCT04012944
NA

SIRONA 2 Trial Heart Failure NYHA Class III

Sponsor: Endotronix, Inc.

View on ClinicalTrials.gov

Summary

This is a prospective, multi-center, open-label, single-arm CE-Mark trial to assess device safety and efficacy of the Cordella PA Sensor System in up to 75 New York Heart Association (NYHA) Class III Heart Failure patients who will receive the Cordella PA Sensor Implant.

Official title: A Prospective, Multi-Center, Open-Label, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients (SIRONA 2 Trial)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2019-06-26

Completion Date

2027-07

Last Updated

2025-08-07

Healthy Volunteers

No

Interventions

DEVICE

Cordella™ Pulmonary Artery Sensor System

The Cordella PA Sensor System comprises seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation. 1. Cordella Sensor 2. Cordella Delivery System 3. myCordella Patient Reader 4. Reader Dock 5. Cordella Calibration Equipment (CalEQ) 6. myCordella Hub 7. Cordella Data Analysis Platform (CDAP).

Locations (7)

Cardivascular Center OLV Aalst

Aalst, Belgium

Ziekenhuis- Oost Limburg

Genk, Belgium

Uniklinik Köln, Klinik III für Innere Medizin Herzzentrum der Universität zu Köln

Cologne, Germany

Universitätsklinikum Giessen und Marburg GmbH, Standort Giessen Medizinische Klinik I, Abteilung Kardiologie und Angiologie

Giessen, Germany

Klinik für Kardiologie und Angiologie/ Studienambulanz Medizinische Hochschule Hannover (MHH)

Hanover, Germany

Mater Misericordiae University Hospital

Dublin, Ireland

University Hospital Galway

Dublin, Ireland