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EPX-HTG for Structural Heart Procedures

NCT07705425 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-15

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)
  • Mitral Valve (MV) Regurgitation

Interventions

DEVICE

Left Atrial Appendage Occlusion

Left Atrial Appendage Occlusion with HTG as an additive visualization tool for procedure guidance.

DEVICE

Mitral Valve Transcatheter Edge to Edge Repair

Mitral Valve Transcatheter Edge to Edge Repair with HTG as an additive visualization tool for procedure guidance.

Sponsors & Collaborators

  • EchoPixel, Inc.

    lead INDUSTRY

Principal Investigators

  • Gagan D Singh, MD · UC Davis Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2026-12-31
Completion
2027-10-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705425 on ClinicalTrials.gov