SIRONA Trial Heart Failure NYHA Class III

Heart Failure NYHA Class III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03375710
• Other study ID #: ETX-HFS-PA-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: February 28, 2029

Study information

• Verified date: May 2024
• Source: Endotronix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: February 28, 2029
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject has given written informed consent

2. Male or female, at least 18 years of age

3. Diagnosis of HF = 3 months with either preserved or reduced left ventricular ejection fraction (LVEF)

4. Diagnosis of NYHA Class III HF at the time of Screening with at least 1 HF-related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit within the last year

5. Subjects must be receiving appropriate medical management of HF for 3 months prior to Screening and clinically stable for at least 1 month prior to study entry

6. Subjects with a Body Mass Index (BMI) < 35 kg/mL2 and chest circumference < 1050 mm

7. Subjects with right pulmonary artery branch diameter sized between 14 mm and 20 mm (target Sensor implant site) over a length of at least 30mm

8. Subjects with distance between target implant site (right PA branch) and ventral thoracic skin surface of < 12cm

9. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 600g) against the ventral thoracic surface for up to 2 minutes per day while in a seated. position, as well as dock and undock the myCordella™ Patient Reader

10. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient Reader.

11. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home

12. Subject agrees to return to the treating Investigator for all scheduled follow up visits and can return to the hospital for follow up

13. Subject compliance as defined by data collection and transmissions at least 5 days a week (does not have to be consecutive days) using the myCordella™ Hub & Peripherals for at least 1 week during the screening period

Exclusion Criteria:

1. Subjects with primary pulmonary hypertension.

2. Subjects with an active infection at the Sensor Implant Visit

3. Subjects with history of recurrent (> 1) pulmonary embolism or deep vein thrombosis

4. Subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of the Screening Visit

5. Subjects whereby RHC or computed tomography pulmonary angiography (CTPA) is contraindicated

6. Subjects with a Cardiac Resynchronization Device (CRT), Internal Cardiac Defibrillator (ICD) or pacemaker (if implanted less than 6 months or has more than a single lead), or Left Ventricular Assist Device (LVAD)

7. Any major surgery within 30 days of the Sensor Implant Visit.

8. Subjects with a Glomerular Filtration Rate (GFR) <30 ml/min or who are on chronic renal dialysis

9. Specific liver enzymes [Aspartate Aminotransferase (AST) (SGOT), and Alanine Aminotransferase (ALT) (SGPT) >3 times the upper limit of normal

10. Subjects likely to undergo lung and/ or heart transplantation within 24 months of the Screening Visit.

11. Subjects with congenital heart disease or mechanical/tissue right heart valve(s)

12. Subjects with known coagulation disorders

13. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take dual antiplatelet or anticoagulants for one month post implant

14. Subjects enrolled in another investigational trial.

15. Known history of life threatening allergy to contrast dye.

16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance

17. Subjects with large metal implants/prostheses or any other materials in the thoracic cavity that may interfere with the Cordella™ Pulmonary Artery Sensor System performance

18. Subjects with an indwelling inferior vena cava (IVC) filter

19. Subjects who are pregnant or breastfeeding

20. Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study

21. Severe illness, other than heart disease, which would limit survival to <1 year

22. Subjects who have had intractable arrhythmias within 2 month of the Screening Visit

23. Subjects with patent foramen ovale (PFO)

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class III

Intervention

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: myCordella™ Patient Management Portal myCordella™ Hub myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk
Ireland	Galway University Hospital	Galway

Sponsors (1)

Lead Sponsor	Collaborator
Endotronix, Inc.

Countries where clinical trial is conducted

Belgium,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Freedom form Adverse events	Freedom from adverse events associated with use of the Cordella™ HF System	30 days
Primary	Efficacy: Accuracy	Accuracy of Cordella™ Sensor PA pressure measurements, compared to standard-of-care fluid-filled catheter PA pressure measurements obtained by standard Right Heart Catheter	90 days
Secondary	Frequency of Adverse Events	Frequency of adverse events throughout the study	30 days and 2 years
Secondary	Device/system-related complications	Device/system-related complications	30 days and 2 years
Secondary	Pressure sensor failure rate	Pressure sensor failure rate throughout the study	30 days and 2 years
Secondary	Accuracy of Cordella™ sensor pressure measurements	Accuracy of Cordella™ Sensor PA pressure measurements compared with echo pulmonary artery pressure (PAP) measurements	2 years
Secondary	Percentage of device success	Percentage of device success as documented by ability of the System to successfully transmit collected data to a secure database	90 days
Secondary	Change in Pulmonary Artery (PA) pressure	Change in PA pressure pre- and post-implant	90 days
Secondary	Heart Failure (HF) Hospitalizations	Frequency of HF hospitalizations, HF treatments in a hospital day-care setting, or urgent outpatient clinic HF visits.	90 days
Secondary	Quality of Life	Quality of Life measured by KCCQ	90 days and 2 years
Secondary	Quality of Life	Quality of Life measured by EuroQOL EQ-5D-5L	90 days and 2 years
Secondary	Adherence to regular myCordella™ Peripherals measurements	Adherence to regular myCordella™ Peripherals measurements	90 days and 2 years