EPX-HTG for Structural Heart Procedures

Part of paid clinical trials in Sacramento, California.

Sponsor
EchoPixel, Inc.
Study ID
NCT07705425
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Left Atrial Appendage Occlusion — DEVICE
    Left Atrial Appendage Occlusion with HTG as an additive visualization tool for procedure guidance.
  • Mitral Valve Transcatheter Edge to Edge Repair — DEVICE
    Mitral Valve Transcatheter Edge to Edge Repair with HTG as an additive visualization tool for procedure guidance.

Study Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Aug 3, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Oct 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EPX-HTG
    Patients undergoing structural heart procedures (LAAO or M-TEER) including Holographic Therapy Guidance (HTG) as an additive visualization tool for procedure guidance.

Primary Outcome Measure

Optimal Device Position. [ Time Frame: 45 days post procedure. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, DavisSacramentoCalifornia95187-

Find similar trials in Sacramento, CA

By research site
University of California, Davis· Sacramento, CA

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