Atrial Fibrillation (AF)EPX-HTG-2026NCT07705425
EPX-HTG for Structural Heart Procedures
A study testing Left Atrial Appendage Occlusion and Mitral Valve Transcatheter Edge to Edge Repair in people with Atrial Fibrillation (AF) and Mitral Valve (MV) Regurgitation, run by EchoPixel, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
- What is being tested?
- Left Atrial Appendage Occlusion and Mitral Valve Transcatheter Edge to Edge Repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients whose procedures would require a GE or Siemens ultrasound system.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Davis
Sacramento, California, 95187
About this study
Official title: EchoPixel Holographic Therapy Guidance (HTG) for Structural Heart Procedures
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.
Read more
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.
Read the detailed description
A prospective, single-center, clinical chart review.
In this trial, we will determine if the additional use of EchoPixel - HTG demonstrates a reduction in procedure time, decrease use of contrast and radiation, minimize the number of devices trialed during a procedure, determine ideal fluoroscopic viewing angles for device deployment, and optimize implant deployment and seal in in Structural Heart (SH) procedures.
The study team will compile the redacted pre- procedure CT, redacted procedural Trans-Esophageal Echo (TEE) or Intra-Cardiac Echo (ICE), procedural fluoroscopic imaging and the post device implant imaging created for each procedure case. Patient health information will be redacted and provided to physicians for review. Data will be collected on case report forms.
A prospective review will occur of outcomes regarding the Structural Heart (SH) procedure cases and data will be recorded on case report forms to compare to normal historical outcomes.
All available consecutive patients treated with the Watchman FLX device for Left Atrial Appendage Occlusion (LAAO) or MitraClip for Mitral Valve transcatheter edge to edge repair (M-TEER) will be reviewed. The primary endpoint will be to determine if EchoPixel - HTG assists in better guiding the implanter during the procedure.
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.
The Primary objective of the study is to determine if adding EchoPixel - HTG has a positive impact on optimal procedure success for patients undergoing an implantation of a Watchman FLX / MitraClip device compared to patients with current SIG. Procedural metrics and any procedural related complications will be recorded as secondary outcomes.
Patient demographics blinded procedural outcomes, pre-hospital discharge and complications will be monitored through and until the patient follow-up visit.
Study Execution.
Collection of data:
- All patients will be identified using a prospective review.
- The patients imaging will be de-identified and numbered with randomly picked research subject numbers identified only by site enrollment log (retained at the site only).
- All deidentified data imaging will be downloaded on the two separate BOX (part 11 FDA compliant) drives.
- CT data in one drive.
- TEE data in one drive.
- ICE data in one drive.
- All patient's demographics will be obtained (age, ethnicity, vitals, ejection fraction, EKG, hemoglobin, creatinine, medical history, concomitant medications, CHADS2-Vasc, HAS-BLED, primary reason for implant).
Analysis of procedural data:
- Procedure time in minutes.
- Fluoroscopic time in minutes.
- Radiation dose in mGy.
- Contrast used during the LAAO procedure in ml.
- Number of devices trialed during the LAAO / TEER procedure.
- Number of attempted device deployments / recaptures.
- Clinical outcomes and procedural related complications.
- Composite of procedure-related complications through follow-up visit.
Informed Consent Process. This is a prospective trial, utilizing redacted personal health information (PHI). Therefore, consent will be obtained.
Privacy, Confidentiality and Data Handling. The investigator will retain all regulatory documents pertaining to this study in compliance with ICH/GCP guidelines. This includes essential study documents and source documentation that support the data collected on the study Subjects. Each subject's study data will be collected and will be securely stored in the coordinating site's office. Subjects will be identified using a subject identification number. Subject information will be anonymized for data analysis.
RISKS to PARTICIPANTS. As a prospective study, all patients will be managed according to the practice's standard-of-care. As a result, there are no additional risks to the patients having their medical charts reviewed for this study. Staff and employees at the study site have extensive HIPAA training and all records will be retained at the institution. Data collection will involve the recording of protected health information; however, this PHI data will remain at the study site and only de-identified data will be shared with Echopixel. The Watchman FLX procedure / MitraClip is an FDA approved procedure.
BENEFITS to PARTICIPANTS. As an FDA approved device and procedure, there is no direct benefit to the patient. However, information gained from the study will contribute to the body of knowledge regarding the treatment of patients needing the LAAO/MitraClip procedure. Additionally, future patients who may want to consider a LAAO/MitraClip procedure will benefit from the collective published literature base of studies, such as this proposed study.
- Being tested
- Left Atrial Appendage Occlusion, Mitral Valve Transcatheter Edge to Edge Repair
- Keywords
- Structural Heart, Interventional Cardiology, Mitral Valve Transcatheter Edge to Edge Repair, M-TEER, LAAO, Left Atrial Appendage Occlusion
- Medical subject headings
- Atrial Fibrillation, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage OcclusionDevice
Also called Watchman
Left Atrial Appendage Occlusion with HTG as an additive visualization tool for procedure guidance.
Mitral Valve Transcatheter Edge to Edge RepairDevice
Also called MitraClip, M-TEER
Mitral Valve Transcatheter Edge to Edge Repair with HTG as an additive visualization tool for procedure guidance.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Left Atrial Appendage Occlusion; Device: Mitral Valve Transcatheter Edge to Edge Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 days post procedure.
Secondary outcomes (7)
Procedure Time.
Duration of procedure to implant LAAO or TEER device, in minutes.
Measured: Perioperative/Periprocedural measurement of procedure length/duration.
Fluoroscopic Time.
Duration/length of use of fluoroscopy to implant LAAO or TEER device, in minutes.
Measured: Perioperative/Periprocedural measurement of length/duration of fluoroscopy use.
Radiation Dose.
Amount of radiation used to implant LAAO or TEER device in mGy.
Measured: Perioperative/Periprocedural measurement of total radiation dose for completing procedure/surgery.
Contrast Used.
Amount of radio-opaque contrast used to implant LAAO or TEER device, in ml.
Measured: Perioperative/Periprocedural measurement of total radio-opaque contrast used for completing procedure/surgery.
Number of devices trialed for procedure completion.
The total number of devices (LAAO or TEER) utilized/required to complete the procedure.
Measured: Perioperative/Periprocedural count of the total number of devices (LAAO or TEER) utilized/required to complete the procedure/surgery.
Number of Device Deployments.
The total number of times a device is positioned for final deployment in order to be released from the delivery catheter.
Measured: Perioperative/Periprocedural count of the total number of times a device is positioned for final deployment in order to be released from the delivery catheter in order to complete the procedure/surgery/
Procedure-related complications.
Composite of any procedure-related complications for LAAO or M-TEER.
Measured: Perioperative/Periprocedural and throughout 45-day follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start3 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, clinical chart review.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EchoPixel, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gagan D Singh, MD, Principal investigator, UC Davis Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705425
- Sponsor's protocol ID
- EPX-HTG-2026
- Acronym
- EPX-HTG-2026
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EchoPixel Holographic Therapy Guidance (HTG) for Structural Heart Procedures
- ClinicalTrials.gov ID
- NCT07705425
- Acronym / sponsor ID
- EPX-HTG-2026 / EPX-HTG-2026
- Keywords
- Structural Heart, Interventional Cardiology, Mitral Valve Transcatheter Edge to Edge Repair, M-TEER, LAAO, Left Atrial Appendage Occlusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- EchoPixel, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prospective, single-center, clinical chart review.
In this trial, we will determine if the additional use of EchoPixel - HTG demonstrates a reduction in procedure time, decrease use of contrast and radiation, minimize the number of devices trialed during a procedure, determine ideal fluoroscopic viewing angles for device deployment, and optimize implant deployment and seal in in Structural Heart (SH) procedures.
The study team will compile the redacted pre- procedure CT, redacted procedural Trans-Esophageal Echo (TEE) or Intra-Cardiac Echo (ICE), procedural fluoroscopic imaging and the post device implant imaging created for each procedure case. Patient health information will be redacted and provided to physicians for review. Data will be collected on case report forms.
A prospective review will occur of outcomes regarding the Structural Heart (SH) procedure cases and data will be recorded on case report forms to compare to normal historical outcomes.
All available consecutive patients treated with the Watchman FLX device for Left Atrial Appendage Occlusion (LAAO) or MitraClip for Mitral Valve transcatheter edge to edge repair (M-TEER) will be reviewed. The primary endpoint will be to determine if EchoPixel - HTG assists in better guiding the implanter during the procedure.
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.
The Primary objective of the study is to determine if adding EchoPixel - HTG has a positive impact on optimal procedure success for patients undergoing an implantation of a Watchman FLX / MitraClip device compared to patients with current SIG. Procedural metrics and any procedural related complications will be recorded as secondary outcomes.
Patient demographics blinded procedural outcomes, pre-hospital discharge and complications will be monitored through and until the patient follow-up visit.
Study Execution.
Collection of data:
- All patients will be identified using a prospective review.
- The patients imaging will be de-identified and numbered with randomly picked research subject numbers identified only by site enrollment log (retained at the site only).
- All deidentified data imaging will be downloaded on the two separate BOX (part 11 FDA compliant) drives.
- CT data in one drive.
- TEE data in one drive.
- ICE data in one drive.
- All patient's demographics will be obtained (age, ethnicity, vitals, ejection fraction, EKG, hemoglobin, creatinine, medical history, concomitant medications, CHADS2-Vasc, HAS-BLED, primary reason for implant).
Analysis of procedural data:
- Procedure time in minutes.
- Fluoroscopic time in minutes.
- Radiation dose in mGy.
- Contrast used during the LAAO procedure in ml.
- Number of devices trialed during the LAAO / TEER procedure.
- Number of attempted device deployments / recaptures.
- Clinical outcomes and procedural related complications.
- Composite of procedure-related complications through follow-up visit.
Informed Consent Process. This is a prospective trial, utilizing redacted personal health information (PHI). Therefore, consent will be obtained.
Privacy, Confidentiality and Data Handling. The investigator will retain all regulatory documents pertaining to this study in compliance with ICH/GCP guidelines. This includes essential study documents and source documentation that support the data collected on the study Subjects. Each subject's study data will be collected and will be securely stored in the coordinating site's office. Subjects will be identified using a subject identification number. Subject information will be anonymized for data analysis.
RISKS to PARTICIPANTS. As a prospective study, all patients will be managed according to the practice's standard-of-care. As a result, there are no additional risks to the patients having their medical charts reviewed for this study. Staff and employees at the study site have extensive HIPAA training and all records will be retained at the institution. Data collection will involve the recording of protected health information; however, this PHI data will remain at the study site and only de-identified data will be shared with Echopixel. The Watchman FLX procedure / MitraClip is an FDA approved procedure.
BENEFITS to PARTICIPANTS. As an FDA approved device and procedure, there is no direct benefit to the patient. However, information gained from the study will contribute to the body of knowledge regarding the treatment of patients needing the LAAO/MitraClip procedure. Additionally, future patients who may want to consider a LAAO/MitraClip procedure will benefit from the collective published literature base of studies, such as this proposed study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, clinical chart review.
| Arm | Type | Receives |
|---|---|---|
| EPX-HTG | Experimental | Device: Left Atrial Appendage Occlusion, Device: Mitral Valve Transcatheter Edge to Edge RepairPatients undergoing structural heart procedures (LAAO or M-TEER) including Holographic Therapy Guidance (HTG) as an additive visualization tool for procedure guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients whose procedures would require a GE or Siemens ultrasound system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage OcclusionAlso: WatchmanLeft Atrial Appendage Occlusion with HTG as an additive visualization tool for procedure guidance. | Device | EPX-HTG |
| Mitral Valve Transcatheter Edge to Edge RepairAlso: MitraClip, M-TEERMitral Valve Transcatheter Edge to Edge Repair with HTG as an additive visualization tool for procedure guidance. | Device | EPX-HTG |
Primary outcome
Optimal Device Position.
Time frame: 45 days post procedure.
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.
7 secondary outcomes
Procedure Time.
Time frame: Perioperative/Periprocedural measurement of procedure length/duration.
Fluoroscopic Time.
Time frame: Perioperative/Periprocedural measurement of length/duration of fluoroscopy use.
Radiation Dose.
Time frame: Perioperative/Periprocedural measurement of total radiation dose for completing procedure/surgery.
Contrast Used.
Time frame: Perioperative/Periprocedural measurement of total radio-opaque contrast used for completing procedure/surgery.
Number of devices trialed for procedure completion.
Time frame: Perioperative/Periprocedural count of the total number of devices (LAAO or TEER) utilized/required to complete the procedure/surgery.
Number of Device Deployments.
Time frame: Perioperative/Periprocedural count of the total number of times a device is positioned for final deployment in order to be released from the delivery catheter in order to complete the procedure/surgery/
Procedure-related complications.
Time frame: Perioperative/Periprocedural and throughout 45-day follow-up visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gagan D Singh, MD principal investigator
UC Davis Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage Occlusion and Mitral Valve Transcatheter Edge to Edge Repair in people with Atrial Fibrillation (AF) and Mitral Valve (MV) Regurgitation, run by EchoPixel, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergio Aguirre, MSc (6503382559 ext. 701, sergio@echopixeltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Device Position. (time frame: 45 days post procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.