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

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: Active, not recruiting
• Conditions: Left Atrial Appendage Closure
• Intervention / Treatment: Other: Intracardiac Echocardiography

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: Interventional
• Enrollment (Estimated): 444
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott and White Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Publications and helpful links

General 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. Erratum In: JAMA. 2015 Mar 10;313(10):1061.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Estimated): December 14, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: March 12, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID 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