Health TrialsbyHealthPanel

EPX-HTG for Structural Heart Procedures

ConditionsAtrial Fibrillation (AF)Mitral Valve (MV) Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEchoPixel, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: EPX-HTGExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
45 days post procedure.

Secondary outcomes

1

Procedure Time.

Duration of procedure to implant LAAO or TEER device, in minutes.

Time frame
Perioperative/Periprocedural measurement of procedure length/duration.
2

Fluoroscopic Time.

Duration/length of use of fluoroscopy to implant LAAO or TEER device, in minutes.

Time frame
Perioperative/Periprocedural measurement of length/duration of fluoroscopy use.
3

Radiation Dose.

Amount of radiation used to implant LAAO or TEER device in mGy.

Time frame
Perioperative/Periprocedural measurement of total radiation dose for completing procedure/surgery.
4

Contrast Used.

Amount of radio-opaque contrast used to implant LAAO or TEER device, in ml.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EchoPixel, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: