Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Left Atrial Appendage Closure Clinical Trial

— ICETEE  

Official title:

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06348394
• Other study ID #: 023-318
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 14, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 444
• Est. completion date: December 30, 2025
• Est. primary completion date: December 14, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed for non-valvular atrial fibrillation with elevated CHADSVASC and HASBLED scores, meeting commercial LAAO criteria indications, who underwent appropriate pre-procedural imaging with Computed tomography or transesophageal echocardiography.

2. Patients with increased risk of stroke with elevated CHA2DS2-VASc score.

3. Patients who cannot be on oral anticoagulants or can't tolerate these medications.

4. Patient should be able to comply with the protocol.

5. Provide written informed consent before study participation.

6. Ages 18 and above

Exclusion 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 left ventricle dysfunction- Left ventricular ejection fraction (LVEF < 40%) or greater than moderate valvular heart disease.

4. Enrollment in another study that competes or interferes with this study.

5. Poor clinical condition like cardiogenic shock, which prohibits pre- and post-procedural function tests.

6. Subject with planned complex PCI or procedure necessitating multiple intervention.

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. 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.

Related Conditions & MeSH terms

• Left Atrial Appendage Closure

Intervention

Other:
• Intracardiac Echocardiography
Transesophageal echocardiography will be performed under general anesthesia.

Locations

Country	Name	City	State
United States	Baylor Scott and White Heart Hospital	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hemam 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. — View Citation

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. Erratum In: JAMA. 2015 Mar 10;313(10):1061. — View Citation

Tzikas 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Intra op
Secondary	Periprocedural complications	Pericardial effusion/tamponade measured as (Yes/No)	45 days after the procedure
Secondary	Procedural characteristics	Total duration measured as number of minutes.	45 days after the procedure
Secondary	Patient satisfaction	Patient satisfaction will be assessed in-hospital by a questionnaire addressing anesthesia-related discomfort.	45 days after the procedure
Secondary	Periprocedural complications	Stroke measured as (Yes/No)	45 days after the procedure
Secondary	Periprocedural complications	Death measured as (Yes/No)	45 days after the procedure
Secondary	Procedural characteristics	Fluoroscopy time measured as number of minutes.	45 days after the procedure
Secondary	Procedural characteristics	Contrast volume measured in milli liters.	45 days after the procedure
Secondary	Procedural characteristics	Length of hospital stay measured as number of days.	45 days after the procedure