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PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients
 
Region Sponsors
California - Northern
Endotronix, Inc
 
Acronym KP IRB No.
1482088
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
(Adult, Older Adult) with diagnosis and treatment of Heart Failure NYHA Class III
 
Purpose
This is a prospective, randomized, controlled, single blind, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure Patients
 
Detailed Description
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • Subject has given written informed consent
  • Male or female, at least 18 years of age
  • Diagnosis and treatment of HF (regardless of left ventricular ejection fraction (LVEF)) for >3 months and NYHA Class III HF at time of Screening
  • 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, with any intolerance documented
  • 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: * (a) Subjects with LVEF <50%: NT-proBNP >1500 pg/mL. * (b) 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
  • Subjects should be on diuretic therapy
  • 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
  • Please contact study team for additional inclusion/exclusion criteria
 
Exclusion Criteria
  • Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNI), and beta-blockers) due to hypotension or renal dysfunction
  • ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
  • 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)
  • Subjects who have had a major cardiovascular (CV) event (e.g., myocardial infarction, stroke) within 3 months of the Screening Visit
  • Unrepaired severe valvular disease
  • Subjects with congenital heart disease or mechanical/tissue right heart valve(s)
  • Subjects with known coagulation disorders
  • 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
  • Known history of life threatening allergy to contrast dye
  • Please contact study team for additional inclusion/exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Heart Failure
  • Heart Disease
  • Cardiovascular Disease
  • Pulmonary Artery Pressure
  • ETX-HFS-PA-03
  • Cardiology
 
KP Clinical Facility
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Cardiology


Principal Investigator:
Jana Svetichnaya, MD
Contact Information:
- Sirtaz Adatya, MD
-Santa Clara Medical Center-Homestead


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