PROACTIVE-HF IDE Trial Heart Failure NYHA Class III

Heart Failure NYHA Class III Clinical Trial

— PROACTIVE-HF  

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 NYHA Class III Heart Failure Patients (PROACTIVE- HF Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04089059
• Other study ID #: ETX-HFS-PA-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: April 2028

Study information

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

Clinical Trial Summary

This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients compared to a Performance Goal (PG).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 457
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• 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 and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for = 3 months and NYHA Class III HF at time of Screening

4. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, with any intolerance documented.

5. HF related hospitalization, HF treatment in a hospital day-care setting, or urgent outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as:

1. Subjects with LVEF = 50%: NT-proBNP = 1500 pg/mL.

2. Subjects with LVEF > 50%: NT-proBNP = 800 pg/mL . Thresholds for NT-proBNP (for both LVEF = 50% and LVEF > 50%) will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2

6. Subjects should be on diuretic therapy

7. Subjects who are physically able to hold the myCordella™ Patient Reader unit (approximate weight 1.3lb) 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

8. 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

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

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

Exclusion Criteria

1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI, and beta-blockers) due to hypotension or renal dysfunction

2. ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)

3. Subjects with history of recurrent pulmonary embolism ( =2 episodes within 5 years prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening Visit)

4. Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction, stroke) within 3 months of the Screening Visit

5. Unrepaired severe valvular disease

6. Subjects with significant congenital heart disease that has not been repaired and would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart valve(s)

7. Subjects with known coagulation disorders

8. 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

9. Known history of life threatening allergy to contrast dye

10. Subjects whereby RHC is contraindicated

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

12. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis

13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit

14. Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months

15. Subjects who are pregnant or breastfeeding

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

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

19. Subjects enrolled in another investigational trial with an active treatment arm

20. Subject who is in custody by order of an authority or a court of law

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class III

Intervention

Device:
• Cordella™ Pulmonary Artery Sensor System
The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of 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. Cordella Sensor Cordella Delivery System myCordella Patient Reader Reader Dock Cordella Calibration Equipment (CalEQ) myCordella Hub Cordella Data Analysis Platform (CDAP)

Locations

Country	Name	City	State
Belgium	Cardiovascular Center OLV Aalst	Aalst
Belgium	ZNA Middlheim	Antwerp
Belgium	Ziekenhuis- Oost Limburg	Genk
Belgium	AZ Glorieux Ronse	Ronse
Ireland	University Hospital Galway	Galway
United States	Thomas Jefferson Abington	Abington	Pennsylvania
United States	Piedmont Athens	Athens	Georgia
United States	Austin Heart	Austin	Texas
United States	Medstar	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Ascension St Vincent's	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts
United States	Brigham and Women's Hospital (Mass General Brigham)	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Northwestern	Chicago	Illinois
United States	U of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	PRISMA Midlands - Palmetto	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Craig Cardiovascular Center	Gonzales	Texas
United States	PRISMA Health- Upstate	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Health	Hershey	Pennsylvania
United States	Queens Medical Center	Honolulu	Hawaii
United States	Baylor/Texas Heart	Houston	Texas
United States	Houston Methodist	Houston	Texas
United States	University of Texas/Hermann Memorial	Houston	Texas
United States	Huntsville Hospital	Huntsville	Alabama
United States	Ascension St Vincent's	Indianapolis	Indiana
United States	University of Iowa Medical Center	Iowa City	Iowa
United States	St. Lukes/ Mid-American Heart Institute	Kansas City	Missouri
United States	University of Kansas Medical Center (KUMC)	Kansas City	Kansas
United States	Tennova Healthcare (Turkey Creek Medical Center)	Knoxville	Tennessee
United States	South Denver Cardiology	Littleton	Colorado
United States	Loma Linda University	Loma Linda	California
United States	University Of Louisville	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Baptist Health South Florida	Miami	Florida
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	West Virginia University	Morgantown	West Virginia
United States	Vanderbilt	Nashville	Tennessee
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Mount Sinai	New York	New York
United States	NYU Langone Health	New York	New York
United States	Sentara Healthcare	Norfolk	Virginia
United States	Heart Centers of Illinois	Palos Park	Illinois
United States	Ascension Sacred Heart	Pensacola	Florida
United States	OSF Healthcare	Peoria	Illinois
United States	Penn Medicine	Philadelphia	Pennsylvania
United States	Thomas Jefferson	Philadelphia	Pennsylvania
United States	Phoenix Cardiovascular Research Group/Insight	Phoenix	Arizona
United States	UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health Science Portland	Portland	Oregon
United States	New York Presbyterian Queens	Queens	New York
United States	Eisenhower Medical Center	Rancho Mirage	California
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Baylor - Round Rock	Round Rock	Texas
United States	Centra Care Heart Center	Saint Cloud	Minnesota
United States	Methodist Healthcare System	San Antonio	Texas
United States	UCSD	San Diego	California
United States	Kaiser San Francisco	San Francisco	California
United States	UCSF Medical Center	San Francisco	California
United States	Kaiser Santa Clara	Santa Clara	California
United States	University of Washington	Seattle	Washington
United States	Sanford	Sioux Falls	South Dakota
United States	Providence Health Care	Spokane	Washington
United States	Stony Brook University Med Center	Stony Brook	New York
United States	USF Health	Tampa	Florida
United States	Baylor - Temple	Temple	Texas
United States	Cleveland Clinic	Weston	Florida
United States	Valley Health System/Winchester Medical Center	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Endotronix, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy 6 month incidence of HF related Hospitalizations (HFH) or all-cause mortality	6 month incidence of HF related Hospitalizations (HFH) or all- cause mortality compared to a Performance Goal	6 months
Primary	Safety: Freedom from device/system related complication	Freedom from device/system related complication at 6 months	6 months
Primary	Safety: Freedom from pressure sensor failure	Freedom from pressure sensor failure at 6 months	6 months
Secondary	HF Hospitalizations	Number of HF Hospitalizations at 6 and 12 months post-implant compared to the number of HF Hospitalizations in the 6 and 12 months prior to implant	6 months and 12 months
Secondary	HF Hospitalizations or Emergency Department/Hospital Outpatient IV diuretic visits.	Comparison of the number of HF Hospitalizations, Emergency Department/ Hospital Outpatient IV diuretic visits of Cohort #1 and Cohort #2 at 6 and 12 months post implant at 6 months, added together with equal weighting into a total number of events	6 and 12 months
Secondary	Mortality	Cardiac and all-cause mortality	3 years
Secondary	IV diuretic visits	Intravenous (IV) diuretic visits	3 years
Secondary	Pulmonary Artery Pressure (PAP)	Change in PAP: a. From Baseline through 6 and 12 months in subjects with a baseline mPAP i. above target range ii. within or below target range iii. Overall b. Before and after 6-Minute Walk Test	6 and 12 months
Secondary	Device success	Percentage of device success as documented by ability of the System to successfully transmit PAP data transmit PAP data	3 years
Secondary	KCCQ	The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. Out of 23-items, 10 scores will be calculated: Physical Limitation, Symptom Stability, Symptom Frequency, Symptom Burden, Total Symptom Score, Self-Efficacy, Quality of Life, Social Limitation, Overall Summary Score, Clinical Summary Score .Presentation will be done by means of descriptive statistics including the absolute value and change from baseline by visit.	3 years
Secondary	NYHA	Subjects complete a six (6) minute walk test at the study visits described in the study protocol. Total distance walked (meters) will be collected and analyzed by means of descriptive statistics including the absolute value and change from baseline by visit	3 years
Secondary	NYHA and 6-Minute Walk Test	Functional status improvement, as measured by NYHA and 6-Minute Walk Test	3 years
Secondary	Serious adverse events	Frequency of serious adverse events throughout the study	3 years
Secondary	Incidence of HF Hospitalizations or all-cause mortality	Incidence of HF Hospitalizations or all-cause mortality at 12 months	12 months
Secondary	N-terminal pro B-type Natriuretic Peptide (NT-proBNP	Change of N-terminal pro B-type Natriuretic Peptide (NT-proBNP) from Baseline through 6 and 12 months	6 and 12 months
Secondary	Days Alive and Out of Hospital (DAOH)	Days Alive and Out of Hospital (DAOH)	3 years
Secondary	Heart failure related Medication changes	Heart failure related Medication changes	3 years
Secondary	HF Hospitalization or all-cause mortality	Incidence of HF Hospitalizations or all-cause mortality at 12 months	12 months
Secondary	HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits, all-cause mortality	Combined outcome of: First and recurrent Heart Failure Hospitalizations; Emergency Department / Hospital Outpatient IV diuretic visits all-cause mortality at 6 months, added together with equal weighting into a total number of events.	6 months
Secondary	HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits	HF Hospitalization, Emergency Department/Hospital Outpatient IV diuretic visits at 6 and 12 months	6 and 12 months
Secondary	Implant procedure and procedure related adverse events and serious adverse events	Frequency of implant procedure and procedure related adverse events and serious adverse events	3 years