Phase II year
2020
(last award dollars: 2021)
Phase II Amount
$3,961,268
We propose the development and evaluation of a novel implantable low-energy device, using an innovative low-energy approach, to achieve tolerable, nearly pain free treatment of atrial fibrillation. Atrial fibrillation (AF) is a global epidemic. Approximately 33.5 million individuals are affected worldwide and close to 5 million new cases occur each year costing the US healthcare system between $6 and $26 billion annually. Atrial fibrillation is a progressive disease with many patients first developing paroxysmal atrial fibrillation (PAF). Left untreated, PAF can progress to persistent or permanent AF. Because of rapid changes in the atria after AF onset, a therapy to treat AF soon after onset may slow the progressive nature of atrial fibrillation. There exists great enthusiasm in the medical community for AF interventions. Limitations in both pharmacologic and other device-based efforts to treat AF have been disappointing. An effective atrial defibrillator was previously developed; however, it was abandoned due to pain associated with shocks. A tolerable, nearly pain-free, device-based AF therapy approach would address a major unmet medical need. Prior canine and early stage human studies have observed that the proposed therapy approach significantly lowers the energy required for atrial defibrillation. The goal of this proposed direct to phase II project is to develop a prototype AF therapy device and evaluate its performance in a human clinical trial under FDA IDE.
Public Health Relevance Statement: Project Narrative This project relates to the development of a new therapy for treating patients suffering from atrial fibrillation. Atrial fibrillation is a global epidemic. Approximately 33.5 million individuals are affected worldwide and close to 5 million new cases occur each year costing the U.S. healthcare system between $6 and $26 billion annually. Current therapies are falling short and the proposed tolerable, nearly pain-free, device-based atrial fibrillation therapy approach addresses a major unmet medical need.
Project Terms: Ablation; Address; Adoption; Affect; Age-Years; American; Arrhythmia; Atrial Fibrillation; base; Biomedical Engineering; Body Surface; Canis familiaris; Cardiac; Cardiac ablation; Cardiac Electrophysiologic Techniques; Cicatrix; Clinical; Clinical effectiveness; clinical practice; Clinical Trials; Collaborations; Communities; Computer software; Consult; cost; Custom; Data; Defibrillators; Dementia; Department chair; Development; Devices; Doctor of Philosophy; effective therapy; Effectiveness; Elderly; Electric Countershock; Epidemic; Evaluation; exercise capacity; falls; FDA approved; first-in-human; Freedom; Goals; Healthcare Systems; Heart; Heart Atrium; heart function; Heterogeneity; Hospitals; Human; Impairment; Implantable Defibrillators; implantable device; improved; Individual; innovation; Interdisciplinary Study; Intervention; Investigation; Laboratories; Left; lifetime risk; Maintenance; Medical; men; Methods; mortality; Nature; novel; novel therapeutics; Ohio; Pain; Pain-Free; Painless; Pathway interactions; Patient Care; Patients; Performance; Pharmacology; Phase; Physiologic pulse; prevent; Procedures; Progressive Disease; prototype; Quality of life; research and development; Research Personnel; Risk; Safety; safety and feasibility; Sedation procedure; Shock; Sinus; Specific qualifier value; Stroke; Symptoms; System; Testing; therapy development; Thromboembolism; Tissues; translational study; Universities; voltage; Washington; Woman
