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ACCEPT DECLINE

Evidence - Based HF
Management

Learn more about our clinical programs

U.S. & E.U.
PROACTIVE-
HF 2
U.S. & E.U.
PROACTIVE-
HF
E.U.
Sirona 2
E.U.
Sirona FIH
U.S. & E.U.
Cordella System
Commercially Available

PA pressure-guided management is changing how we treat heart failure patients. Endotronix's comprehensive solution is backed by solid clinical evidence and is at the forefront of that shift with a best-in-class experience for patients and clinicians.

– Liviu Klein, MD, Advanced Heart Failure Physician and PROACTIVE-HF National Principal Investigator (PI)

This page is intended for clinician use.

Trial Highlights
PROACTIVE-HF 2 Trial

A prospective, multi-center, open-label, randomized control clinical trial that is designed to expand the indications of the Cordella Sensor and support scaling PA pressure-guided management.

Market expansion to NYHA Class II HF patients
Randomized Arm to demonstrate safety and efficacy of the Cordella Sensor in NYHA Class II HF patients
Scaling PA pressure-guided management
Single Arm to demonstrate safety and efficacy of the Cordella Sensor linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients.
PROACTIVE-HF 2
ENROLLING
# of Patients Enrolled
Up to 1,500
# of Clinical Sites
Up to 120 U.S. and E.U. Sites
Target Patient Population
NYHA Class II & III HF
Primary Endpoints
  • Mortality & HF hospitalizations
  • System & Device safety
Select Secondary Endpoints
Rate of HF Hospitalizations for both study arms
Visit www.clinicaltrials.gov (NCT04089059) for complete trial information.
The Cordella PA Sensor System has received FDA approval for NYHA class III heart failure patients. The PROACTIVE-HF 2 trial is investigating the use of the same Cordella PA Sensor System in NYHA class II heart failure patients. Exclusively for Clinical Investigation.
Download Brochure

Trial Highlights
PROACTIVE-HF IDE Trial

The prospective, multi-center, single-arm clinical trial provided safety and efficacy evidence to support U.S. regulatory submission for the Cordella PA Sensor. 

Met Primary Efficacy endpoint

met primary Safety Endpoint 

99.2%
freedom from DSRC1

99.8%
freedom from sensor failure

improved quality of life

Significant improvement in quality of life
(KCCQ, 6MWT, NYHA)2

6-month Results
THT 2024 Presentation

1 DSRC: device/system related complications
2 Kansas City Cardiomyopathy Questionnaire (KCCQ) +5 pt, 6-minute walk test (6MWT) 23 m improvement, NYHA classification 144 patients improved their NYHA class designation

PROACTIVE-HF
ENROLLMENT COMPLETE
# of Patients Enrolled
> 450 patients implanted
# of Clinical Sites
< 120 U.S. and E.U. Sites
Target Patient Population
NYHA Class III HF
Primary Endpoints
  • Mortality & HF hospitalizations
  • System & Device safety
Select Secondary Endpoints
  • Change in PA pressure
  • Rate of HF hospitalizations
  • HF medication changes
  • Device performance
  • Patient Quality of Life (QoL) metrics
Trial Cost
  • The Cordella Sensor and System was provided without charge to patients enrolled in PROACTIVE-HF
Visit www.clinicaltrials.gov (NCT04089059) for complete trial information.

Read Other PROACTIVE-HF Published Data

Trial Design Rationale
Journal of Cardiac Failure
12-month Control Cohort
HFSA 2023 Presentation

Trial Highlights
SIRONA 2 CE Mark Trial

An open-label, prospective, multi-center, trial that will support CE Mark approval of the
CordellaTM PA Sensor.

Building on the successful first-in-human trial, SIRONA 2 confirmed the safety and efficacy of the
Cordella PA Sensor in NYHA class III heart failure patients.1

 
 
 
 
 
 
1 Sharif F et al. ESC Heart Fail 2024
2 No significant difference in measured mean PA pressure at 90 days as compared to reference catheter measurements.
Visit www.clinicaltrials.gov (NCT04012944) for complete trial information.

Read SIRONA 2 published data

12-month Results
ESC Heart Failure 2024
6-month Results
ESC Heart Failure 2022
SIRONA 2
ENROLLMENT COMPLETE
# of Patients
81 patients enrolled, 70 patients implanted
# of Clinical Sites
8 EU sites across Belgium, Germany and Ireland
Target Patient Population
NYHA Class III HF
Primary Endpoints
  • Device safety
  • Accuracy of PA pressure measurements
Select Secondary Endpoints
  • Rate of HF hospitalizations
  • Device performance
  • Patient Quality of Life (QoL) metrics

Trial Highlights
SIRONA First-in-Human Trial

Results from the dual-center, 19-patient trial presented at AHA 2019 established the clinical safety and
accuracy of the Cordella PA Sensor.

Cordella is an elegant heart failure solution that integrates a PA pressure sensor and a comprehensive patient management platform in one. This study showed the straightforward sensor implantation provides reliable PA pressure measurements.

– Prof. Dr. Wilfred Mullens, Cardiologist, Belgium
 
 
 
 
 
 
1 No significant difference in measured mean PA pressure at 90 days as compared to reference catheter measurements.
2 Defined as invasive treatment or results in patient death or explant of the device.
Visit www.clinicaltrials.gov (NCT03375710) for complete trial information.

Read SIRONA FIH published data

FIH Study Results
European Journal of Heart Failure 2020
FIH Early Results
AHA 2019 Presentation

REAL WORLD
Clinical Experience

My patients are doing better, my team is more efficient with their time and we are able to bill for the patient care time. Cordella is becoming an integral part of our practice.

– William Craig, MD, Cardiologist, Texas

Clinician Resources

HF Management with Cordella
HFSA 2021 Presentation
HF Management with Cordella (Ireland)
National Prevention Conference 2021

Based on prospective cohort study of 12,000+ datapoints to assess utilization of Cordella with 24 heart failure patients over 9+ months at a single site in rural Texas.

Disclaimer: This utilization study has been developed to help you understand Medicare reimbursement for Chronic Care Management for heart failure patients using the Cordella System. This does not replace seeking coding advice from the payer and your institution’s coding and compliance staff. The responsibility for correct coding lies with the provider of services. Please contact your local payer for interpretation of the appropriate codes to use for specific procedures. Endotronix makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare as to the correct form of billing or the amount that will be paid to providers of service. Where reimbursement is requested for the use of a product that may be inconsistent or not expressly specified in the FDA cleared or approved labeling (e.g., instructions for use, operator’s manual, or package insert), consult with your billing advisors or payers for advice on handling such billing issues. Some payers may have policies that make it inappropriate to submit claims for such items or related services.
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