# High-Intensity Ultrasound Ablation for Septal Reduction Therapy of Hypertrophic Cardiomyopathy

> **NIH NIH R01** · OREGON HEALTH & SCIENCE UNIVERSITY · 2022 · $602,903

## Abstract

PROJECT SUMMARY
 Obstructive hypertrophic cardiomyopathy (HCM) causes significant symptoms and morbidity due to left
ventricular outflow tract obstruction (LVOTO). Interventricular septal (IVS) reduction procedures for LVOTO
such as alcohol septal ablation and surgical myectomy relieve symptoms and reduce sudden death risk, but
are often initiated late in the disease process due to their peri-operative risk, anatomic constrains,
complications (particularly atrio-ventricular (AV) block) and limited efficacy. Our laboratory has developed an
attractive approach to IVS reduction therapy (SRT) and obtained preliminary large animal data using a high-
intensity ultrasound (HIU) catheter system for the treatment of oHCM, severe LVOTO and its consequences.
HIU has distinct benefits over existing SRT methods in that it:
 1) is less invasive (delivered via a femoral venous approach to the right ventricle (RV)).
 2) selectively ablates the mid-myocardium while sparing the sub-endocardium (which contains the His-
 Purkinje system), thereby reducing risk of AV block.
 3) does not rely on unpredictable anatomic availability of septal perforator coronary artery branches.
 This proposal will further develop HIU IVS reduction by optimizing lesion size and depth, avoiding the
near-field subendocardium, tracking catheter location/orientation/contact, confirming effective formation non-
invasively, and initiating regulatory work to position us for first-in-human studies with a subsequent award. In
Aim 1, we will use acoustic simulations to design, fabricate and validate optimal HIU transducers and catheters
in ex-vivo models. Aim 2 will develop and test several advanced catheter design features that will confirm
transducer-tissue contact, track catheter location in real time, and confirm effective IVS ablation after HIU
sonication is performed. Aim 3 will study fully-developed HIU catheters in-vivo to determine ability to reduce
IVS thickness (and local myocardial mechanics) over 30 day survival.
 The assembled team includes exerts in therapeutic ultrasound, acoustic physics, echocardiography,
cardiac MRI, large animal research methods, research sonographer, and an HCM clinical researcher who will
help with eventual translation of this work to first-in-man studies. Regulatory consultants will ensure that animal
studies are performed in a Good Labor and Practices (GLP)-compliant manner, positioning our group for an
Investigational Device Exemption for an Early Feasibility Study with subsequent awards.

## Key facts

- **NIH application ID:** 10339776
- **Project number:** 1R01HL160712-01
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** Babak Nazer
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $602,903
- **Award type:** 1
- **Project period:** 2022-03-15 → 2022-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10339776

## Citation

> US National Institutes of Health, RePORTER application 10339776, High-Intensity Ultrasound Ablation for Septal Reduction Therapy of Hypertrophic Cardiomyopathy (1R01HL160712-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10339776. Licensed CC0.

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