Current Clinical Trials

PROACTIVE-HF IDE Trial Heart Failure NYHA Class III
  1. Chanaka Wickramasinghe, MD
    Chanaka Wickramasinghe, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started May 2022
  5. Chanaka Wickramasinghe, MD
  6. Currently not accepting new patients

Description

Summary

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. Device Category: A Experimental/Investigational Risk Level: Significant Risk Device Class: III

Official Title

CLOSED TO ENROLLMENT: PROACTIVE-HF A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordellaâ„¢ Pulmonary Artery Sensor System in NYHA Class III Heart Failure

Keywords

Heart Failure NYHA Class III

Eligibility

for people 18 Years and up
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 Un... more
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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, or current European Society of Cardiology (ESC) guidelines for HF treatment in Europe, 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: Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL. 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 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 Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home 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 Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, 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 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) 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 Subjects whereby RHC is contraindicated Subjects with an active infection at the Sensor Implant Visit Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit Received or are likely to receive an advanced therapy (e.g. mechanical circulatory support or lung or heart transplant) in the next 12 months Subjects who are pregnant or breastfeeding 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 Severe illness, other than heart disease, which would limit survival to <1 year Subjects whose clinical condition, in the opinion of the Investigator, makes them an unsuitable candidate for the study Subjects enrolled in another investigational trial with an active treatment arm Subject who is in custody by order of an authority or a court of law

Lead Scientists at Eisenhower Health

Chanaka Wickramasinghe, MD
Board Certified in Internal Medicine and Cardiology, Chanaka Wickramasinghe, MD, received his medical degree at King’s College London GKT School of Medical Education.  He subsequently moved to the United States for further training and completed his residency at University of Texas Southwestern Medical Center in Dallas. During his residency, he excelled in both academic and leadership roles and was chosen to serve as Chief Resident for the medicine residency program for an additional ... more
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Board Certified in Internal Medicine and Cardiology, Chanaka Wickramasinghe, MD, received his medical degree at King’s College London GKT School of Medical Education.  He subsequently moved to the United States for further training and completed his residency at University of Texas Southwestern Medical Center in Dallas. During his residency, he excelled in both academic and leadership roles and was chosen to serve as Chief Resident for the medicine residency program for an additional year.  

He completed a cardiovascular fellowship at UCLA Medical Center and was again recognized for his leadership and academic excellence and served as Chief Fellow during his final year.

Dr. Wickramasinghe knew at an early age he wanted to pursue medicine as a career. “I was always good at science and was very intrigued with how the body worked,” states Dr. Wickramasinghe. While in his residency program, Dr. Wickramasinghe was exposed to numerous subspecialties, but it was cardiology that best aligned with his personality. “I was drawn by the interaction of pathophysiology, pharmacology and functional anatomy in cardiology and the evidenced-based nature of the specialty.”

Dr. Wickramasinghe strongly believes that patients should be involved in making decisions about their health care, and that it is his role is to provide them with as much information as possible to make the best informed decision. He states, “Shared decision making and good patient-physician relationship is vital to treatment compliance and good long term outcomes.”

In addition to being board certified in Internal Medicine and Cardiology, Dr. Wickramasinghe is also board certified in Echocardiography and Nuclear Cardiology. He has special interests in treating patients with congestive heart failure, cardio-oncology (cardio-toxic effects of chemotherapy) as well as being involved in advanced imaging for structural interventions such as Transcatheter aortic valve replacement (TAVR) and MitraClip.

Co-Investigators

  1. Damon Kelsay, MD

Clinical Study Details

  1. Currently not accepting new patients
  2. study started May 2022
  3. Interventional
  4. December 29, 2023