# Implantable Unpinning Termination Therapy for Cardiac Arrhythmias

> **NIH NIH R44** · CARDIALEN, INC. · 2022 · $999,810

## Abstract

Project Summary/Abstract
We propose the development and evaluation of a novel implantable low-energy device, using an innovative
low-energy multi-pulse therapy, to achieve well-tolerated treatment of ventricular and atrial tachyarrhythmias.
Ventricular arrhythmias (VAs) including ventricular tachycardia (VT) and ventricular fibrillation (VF) are
responsible for 75-80% of Sudden Cardiac Death (SCD) cases. Sudden cardiac death kills nearly 450,000
Americans yearly. In the majority of these patients, the most common initial arrhythmia is sustained VT which
can degrade into VF. A high-energy biphasic shock delivered by an implantable cardiac defibrillator (ICD) is the
only existing therapy to terminate VA when low-energy anti-tachycardia pacing fails. These high energy
shocks are associated with increased mortality and severe pain. Similarly, atrial fibrillation (AF), an atrial
tachyarrhythmia, 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.
AF 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 AF. There exists great
enthusiasm in the medical community for AF interventions due to the limited efficacy of current treatments and
risks to the patients. An effective atrial defibrillator was previously developed; however, it was abandoned due
to pain associated with shocks and rapid battery depletion as a high number of high-energy shocks had to be
delivered. A well-tolerated, low-energy, device-based VA and AF therapy without high-energy shocks would
address a major unmet medical need. Prior canine and early stage acute human studies with a non-
implantable version of the proposed system have observed that the proposed therapy approach significantly
lowers the energy required for effective VT and AF therapy into ranges that have been reported as tolerated by
patients. The goal of this proposed phase IIB project is to develop and test a fully implantable prototype low-
energy therapy device for use in future chronic human studies under IDE exemption involving treatment of VT
and AF.

## Key facts

- **NIH application ID:** 10441274
- **Project number:** 5R44HL107055-05
- **Recipient organization:** CARDIALEN, INC.
- **Principal Investigator:** Jeffrey Peters
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $999,810
- **Award type:** 5
- **Project period:** 2011-02-15 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10441274

## Citation

> US National Institutes of Health, RePORTER application 10441274, Implantable Unpinning Termination Therapy for Cardiac Arrhythmias (5R44HL107055-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10441274. Licensed CC0.

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