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SIRONA Trial Heart Failure NYHA Class III

NCT03375710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-02

No results posted yet for this study

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.

Conditions

  • Heart Failure NYHA Class III

Interventions

DEVICE

Cordella™ Heart Failure System

The Cordella™ Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinicians for assessment, patient communication, and patient-centered heart failure management. The system consists of the following components: 1. myCordella™ Patient Management Portal 2. myCordella™ Hub 3. myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)

Sponsors & Collaborators

  • Endotronix, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Sauerland · Endotronix, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2019-05-28
Completion
2025-08-26

Countries

  • Belgium
  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375710 on ClinicalTrials.gov