Left Atrial Appendage ClosureICETEENCT06348394
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
A study testing Intracardiac Echocardiography and Traditional transesophageal echocardiography in people with Left Atrial Appendage Closure, run by Baylor Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Left Atrial Appendage Closure
- What is being tested?
- Intracardiac Echocardiography and Traditional transesophageal echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 444 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 30 Dec 2030
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
- Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥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.
- Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
- Patient should be able to comply with the protocol.
- Provide written informed consent before study participation.
- Ages 18 and above
Who cannot join
- 1) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
- Presence of an intracardiac thrombus on the preprocedural TEE or CT.
- History of previously implanted device for atrial septal defect or patent foramen ovale.
- Severe LV dysfunction (LVEF < 40%) or greater than moderate valvular heart disease.
- Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
- Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.
Show all 10Show fewer
- Subject with planned cardiac intervention between the time of consenting and up to 60 days post-LAAO.
- 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.
- 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
- Children below 18 years, prisoners and patients who are unable to provide consent are excluded.
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, 1 recruiting
- Recruiting
Baylor Scott and White Heart Hospital
Plano, Texas, 75093
Bonnie Ostergren, 4698144181, Bonnie.Ostergren@BSWHealth.org
Sarah Hale, 4698144845, sarah.hale@bswhealth.org
About this study
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.
Read the 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.
- Conditions
- Left Atrial Appendage Closure
- Being tested
- Intracardiac Echocardiography, Traditional transesophageal echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac EchocardiographyDevice
Transesophageal echocardiography will be performed under general anesthesia.
Traditional transesophageal echocardiographyDevice
Traditional transesophageal echocardiography guided Left atrial appendage closure
| Study group | Role | What they receive |
|---|---|---|
| Intracardiac echocardiography Left atrial appendage closure. | Active comparator | Intra cardiac echocardiography will be performed prior to left atrial appendage closure. Receives: Device: Intracardiac Echocardiography |
| Traditional transesophageal echocardiography guided Left atrial appendage closure | Placebo comparator | Transesophageal Echocardiography will be performed under general anesthesia. Receives: Device: Traditional transesophageal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 measured as:
Peri-device leaks greater than 5 milliliters on color doppler (Yes/No)
Measured: Intra op
Secondary outcomes (8)
Periprocedural complications
Pericardial effusion/tamponade measured as (Yes/No)
Measured: 45 days after the procedure
Procedural characteristics
Total duration measured as number of minutes.
Measured: 45 days after the procedure
Patient satisfaction
Patient satisfaction will be assessed in-hospital by a questionnaire addressing anesthesia-related discomfort.
Measured: 45 days after the procedure
Periprocedural complications
Stroke measured as (Yes/No)
Measured: 45 days after the procedure
Periprocedural complications
Death measured as (Yes/No)
Measured: 45 days after the procedure
Procedural characteristics
Fluoroscopy time measured as number of minutes.
Measured: 45 days after the procedure
Procedural characteristics
Contrast volume measured in milli liters.
Measured: 45 days after the procedure
Procedural characteristics
Length of hospital stay measured as number of days.
Measured: 45 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start25 Feb 2025
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage ClosureStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, parallel controlled, open-label, single center study
- Masking
- None (open label)
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348394
- Sponsor's protocol ID
- 023-318
- Acronym
- ICETEE
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
PubMed 25399274Hemam ME, Kuroki K, Schurmann PA, Dave AS, Rodriguez DA, Saenz LC, Reddy VY, Valderrabano M. Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations. Heart Rhythm. 2019 Mar;16(3):334-342. doi: 10.1016/j.hrthm.2018.12.013.
PubMed 30827462Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.
PubMed 27540038Al-Azizi K, Thomas S, Hajar MBA, Pickering T, McCullough K, Dorton C, Moubarak G, Ma TW, Banwait J, Hale S, Gupta S, DiMaio JM, Szerlip M, Matar R, Aqtash O, Baig I, Trehan S, Potluri S. Intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion: Design and rationale of the ICE-TEE trial. Cardiovasc Revasc Med. 2026 Mar;84:82-87. doi: 10.1016/j.carrev.2025.05.029. Epub 2025 Jun 1.
PubMed 40579293
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
- ClinicalTrials.gov ID
- NCT06348394
- Acronym / sponsor ID
- ICETEE / 023-318
- Conditions
- Left Atrial Appendage Closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 4 Apr 2024 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, parallel controlled, open-label, single center study
| Arm | Type | Receives |
|---|---|---|
| Intracardiac echocardiography Left atrial appendage closure. | Active comparator | Device: Intracardiac EchocardiographyIntra cardiac echocardiography will be performed prior to left atrial appendage closure. |
| Traditional transesophageal echocardiography guided Left atrial appendage closure | Placebo comparator | Device: Traditional transesophageal echocardiographyTransesophageal Echocardiography will be performed under general anesthesia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients diagnosed for non-valvular atrial fibrillation with documented paroxysmal, persistent, or permanent NVAF.
- Deemed to be at high risk of stroke or systemic embolism (SE) defined as a CHADS2 score ≥2 or a CHA2DS2-VASc score ≥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.
- Can undergo appropriate pre-procedural imaging with Computed tomography (CT) or transesophageal echocardiography (TEE).
- Patient should be able to comply with the protocol.
Key exclusion criteria (10 listed)
- 1) A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
- Presence of an intracardiac thrombus on the preprocedural TEE or CT.
- History of previously implanted device for atrial septal defect or patent foramen ovale.
- Severe LV dysfunction (LVEF < 40%) or greater than moderate valvular heart disease.
- Enrollment in another study that competes or interferes with this study. Approval to dual enroll must be approved by the other study.
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 |
|---|---|---|
| Intracardiac EchocardiographyTransesophageal echocardiography will be performed under general anesthesia. | Device | Intracardiac echocardiography Left atrial appendage closure. |
| Traditional transesophageal echocardiographyTraditional transesophageal echocardiography guided Left atrial appendage closure | Device | Traditional transesophageal echocardiography guided Left atrial appendage closure |
Primary outcome
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)
8 secondary outcomes
Periprocedural complications
Time frame: 45 days after the procedure
Procedural characteristics
Time frame: 45 days after the procedure
Patient satisfaction
Time frame: 45 days after the procedure
Periprocedural complications
Time frame: 45 days after the procedure
Periprocedural complications
Time frame: 45 days after the procedure
Procedural characteristics
Time frame: 45 days after the procedure
Procedural characteristics
Time frame: 45 days after the procedure
Procedural characteristics
Time frame: 45 days after the procedure
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 3 Sep 2026.
- Background: PubMed 25399274Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
- Background: PubMed 30827462Hemam ME, Kuroki K, Schurmann PA, Dave AS, Rodriguez DA, Saenz LC, Reddy VY, Valderrabano M. Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations. Heart Rhythm. 2019 Mar;16(3):334-342. doi: 10.1016/j.hrthm.2018.12.013.
- Background: PubMed 27540038Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.
- Derived from this study: PubMed 40579293Al-Azizi K, Thomas S, Hajar MBA, Pickering T, McCullough K, Dorton C, Moubarak G, Ma TW, Banwait J, Hale S, Gupta S, DiMaio JM, Szerlip M, Matar R, Aqtash O, Baig I, Trehan S, Potluri S. Intracardiac versus transesophageal echocardiographic guidance for left atrial appendage occlusion: Design and rationale of the ICE-TEE trial. Cardiovasc Revasc Med. 2026 Mar;84:82-87. doi: 10.1016/j.carrev.2025.05.029. Epub 2025 Jun 1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracardiac Echocardiography and Traditional transesophageal echocardiography in people with Left Atrial Appendage Closure, run by Baylor Research Institute 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Sep 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. Some participants in this study may receive a placebo. 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 Bonnie Ostergren (4698144181, Bonnie.Ostergren@BSWHealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success following implantation of the left atrial appendage occlusion (LAAO) device. (time frame: Intra op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348394, which also lists 4 linked publications.
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 3 Sep 2026.