EPX-HTG for Structural Heart Procedures

NCT07705425 | Not Yet Recruiting FDA Device

• 1 other identifier: EPX-HTG-2026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Structural Heart; Interventional Cardiology; Mitral Valve Transcatheter Edge to Edge Repair; M-TEER; LAAO; Left Atrial Appendage Occlusion

Outcome Measures

Primary Outcomes (1)

• Optimal Device Position.

  For both LAAO and M-TEER procedures an optimal device position will be established in pre-procedure planning. The optimal device position will be evaluated at the time of the procedure and in post-procedure imaging.

  45 days post procedure.

Secondary Outcomes (7)

• Procedure Time.

  Perioperative/Periprocedural measurement of procedure length/duration.

• Fluoroscopic Time.

  Perioperative/Periprocedural measurement of length/duration of fluoroscopy use.

• Radiation Dose.

  Perioperative/Periprocedural measurement of total radiation dose for completing procedure/surgery.

• Contrast Used.

  Perioperative/Periprocedural measurement of total radio-opaque contrast used for completing procedure/surgery.

• Number of devices trialed for procedure completion.

  Perioperative/Periprocedural count of the total number of devices (LAAO or TEER) utilized/required to complete the procedure/surgery.

Study Arms (1)

EPX-HTG

EXPERIMENTAL

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

Device: Left Atrial Appendage Occlusion; Device: Mitral Valve Transcatheter Edge to Edge Repair

Interventions

Left Atrial Appendage Occlusion DEVICE

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

Also known as: Watchman

EPX-HTG

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.

Also known as: MitraClip, M-TEER

EPX-HTG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients 18 and older scheduled for LAAO or M-TEER at the study site and whose procedure will use Philips CVx TEE or 3D ICE.

You may not qualify if:

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

Sponsors & Collaborators

• EchoPixel, Inc.: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95187, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Gastroesophageal Reflux

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Gagan D Singh, MD

  UC Davis Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Aguirre, MSc

CONTACT

6503382559; sergio@echopixeltech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, clinical chart review.

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)