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Not Yet Recruiting NCT07705425

EPX-HTG for Structural Heart Procedures

Conditions: Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: EchoPixel, Inc.

Location: University of California, Davis Sacramento California

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Patients whose procedures would require a GE or Siemens ultrasound system.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07705425). StuddyBuddy aggregates publicly available trial information.