EchoPixel HTG for Structural Heart Conditions

(EPX-HTG-2026 Trial)

SA
Overseen BySergio Aguirre, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: EchoPixel, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.

Current structural heart (SH) procedures rely on standard image guidance (SIG) relies on 2D X-plane or multiplanar reformatted (MPR) views that can conceal critical anatomy elements at the time of implant or therapy delivery which are crucial to achieve an optimal long term durable outcome.

This limitation complicates an operator's task of optimally implanting a 3D device, delivered by tools that rotate and maneuver in 3D, within a dynamic 3D anatomy, the heart. Slight mismatches between the device and the target in the heart are indicative of a sub-optimal device position, a key risk-factor of peri-device leak (PDL) and other complications.

The primary objective of the study is to determine if including EchoPixel - HTG as an additive visualization procedural tool has a positive impact on optimal procedure outcomes for patients undergoing in Structural Heart (SH) procedures.

Who Is on the Research Team?

GD

Gagan D Singh, MD

Principal Investigator

UC Davis Health

Are You a Good Fit for This Trial?

This trial is for adults with heart conditions like atrial fibrillation, mitral regurgitation, or GERD who are scheduled for certain heart procedures (left atrial appendage occlusion or mitral valve repair). Specific inclusion and exclusion criteria were not detailed.

Inclusion Criteria

I am 18 or older and scheduled for LAAO or M-TEER using Philips CVx TEE or 3D ICE.

Exclusion Criteria

Patients whose procedures would require a GE or Siemens ultrasound system.

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests whether using EchoPixel Holographic Therapy Guidance—a new 3D imaging tool—alongside standard care improves the accuracy and outcomes of structural heart procedures compared to standard imaging alone.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: EPX-HTGExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

EchoPixel, Inc.

Lead Sponsor