Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion (ICETEE)

April 13, 2026 updated by: Baylor Research Institute
This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography (ICE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices.

Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks >5 mm on color doppler.

Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
  2. Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥3.
  3. Patient suitable for OAC with warfarin or DOAC and have appropriate rationale to seek a nonpharmacologic alternative to long-term OAC, meeting commercial LAAO criteria indications.
  4. Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
  5. Patient should be able to comply with the protocol.
  6. Provide written informed consent before study participation.
  7. Ages 18 and above

Exclusion Criteria

1) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:

  1. Presence of an intracardiac thrombus on the preprocedural TEE or CT.
  2. History of previously implanted device for atrial septal defect or patent foramen ovale.
  3. Severe LV dysfunction (LVEF < 40%) or greater than moderate valvular heart disease.
  4. Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
  5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
  6. Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
  7. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
  8. For women of childbearing potential: Pregnant or breastfeeding women or planning pregnancy during the course of the investigation are excluded due to the risks involved in the procedure
  9. Children below 18 years, prisoners and patients who are unable to provide consent are excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intracardiac echocardiography Left atrial appendage closure.
Intra cardiac echocardiography will be performed prior to left atrial appendage closure.
Other: Intracardiac Echocardiography
Transesophageal echocardiography will be performed under general anesthesia.
Other Names:
  • Transesophageal Echocardiography
Placebo Comparator: Traditional transesophageal echocardiography guided Left atrial appendage closure
Transesophageal Echocardiography will be performed under general anesthesia.
Other: Intracardiac Echocardiography
Transesophageal echocardiography will be performed under general anesthesia.
Other Names:
  • Transesophageal Echocardiography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedural success following implantation of the left atrial appendage occlusion (LAAO) device.
Time Frame: Intra op

Procedural success specifies that the device should be implanted in the correct position measured as:

Peri-device leaks greater than 5 milliliters on color doppler (Yes/No)
Intra op

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Periprocedural complications
Time Frame: 45 days after the procedure
Pericardial effusion/tamponade measured as (Yes/No)
45 days after the procedure
Procedural characteristics
Time Frame: 45 days after the procedure
Total duration measured as number of minutes.
45 days after the procedure
Patient satisfaction
Time Frame: 45 days after the procedure
Patient satisfaction will be assessed in-hospital by a questionnaire addressing anesthesia-related discomfort.
45 days after the procedure
Periprocedural complications
Time Frame: 45 days after the procedure
Stroke measured as (Yes/No)
45 days after the procedure
Periprocedural complications
Time Frame: 45 days after the procedure
Death measured as (Yes/No)
45 days after the procedure
Procedural characteristics
Time Frame: 45 days after the procedure
Fluoroscopy time measured as number of minutes.
45 days after the procedure
Procedural characteristics
Time Frame: 45 days after the procedure
Contrast volume measured in milli liters.
45 days after the procedure
Procedural characteristics
Time Frame: 45 days after the procedure
Length of hospital stay measured as number of days.
45 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baylor Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 023-318

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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