Evidence-based insights | The impact of Cordella

PA pressure-guided management is changing how we treat heart failure patients. Backed by solid clinical evidence, Cordella 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.

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.

Evaluating the Cordella PA Sensor in NYHA Class II HF Patients

Randomized Arm to assess safety and efficacy of the Cordella PA Sensor in NYHA Class II HF patients

Scaling PA pressure-guided management

Single Arm to assess 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

1,650

# 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.

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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
JACC Heart Failure

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

12-month Results HFSA 2024 Presentation

Trial Design Rationale
Journal of Cardiac Failure

12-month Control Cohort
HFSA 2023 Presentation

An open-label, prospective, multi-center, trial that is intended to support CE Mark approval of the Cordella 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

87%

of patients prefer taking their reading in the seated position versus lying down

95%

Patient compliance with daily measurements at 12 months

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.clinicaltrial.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

The dual-center, 19-patient trial presented at AHA 2019 evaluated 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.clinicaltrial.gov (NCT03375710) for complete trial information.

Evidence - Based HF
Management

Learn more about our clinical programs

PA pressure-guided management is changing how we treat heart failure patients. Backed by solid clinical evidence, Cordella 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)

PROACTIVE-HF 2 Trial