# Novel Therapy System for Atrial Fibrillation

> **NIH NIH R44** · CARDIALEN, INC. · 2020 · $1,605,396

## Abstract

Project Summary/Abstract
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.

## Key facts

- **NIH application ID:** 10081026
- **Project number:** 1R44HL154937-01
- **Recipient organization:** CARDIALEN, INC.
- **Principal Investigator:** David W Bourn
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,605,396
- **Award type:** 1
- **Project period:** 2020-09-02 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10081026

## Citation

> US National Institutes of Health, RePORTER application 10081026, Novel Therapy System for Atrial Fibrillation (1R44HL154937-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10081026. Licensed CC0.

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