Clinical trial NCT06061757: Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Official title: Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.

Detailed description: Standard intraprocedural guidance for transcatheter left atrial appendage closure (LAAC) employs a multi-modality integrated approach combining fluoroscopy for guiding the delivery system, and transesophageal echocardiography (TEE) for intracardiac characterization to guide device selection and monitor procedural complications. Successful implantation of the device is confirmed with contrast-enhanced fluoroscopy and color doppler flow imaging on TEE. TEE is the current gold standard for procedural guidance but requires general anesthesia (GA) to avoid patient motion and discomfort during the procedure. General anesthesia, however, is associated with pulmonary complications and patient discomfort due to endotracheal intubation. Intraprocedural LAAC guidance under local anesthesia or conscious sedation might help mitigate these GA-related disadvantages and has motivated multiple clinical studies, establishing intracardiac echocardiography (ICE) as a safe and feasible alternative to TEE.

The new generation of NuVision ICE catheter offers a larger imaging volume of 90° x 90° with multiplanar reformatted (MPR) echo views for better visualization of anatomical landmarks and procedural guidance and aid in sizing of the device. This has a potential to improve outcomes and reduce procedure times while lowering healthcare costs.

In this study, Role of NuVision Intracardiac Echocardiographic (ICE) catheter with Tranesopheal echocardiography (TEE) in predicting intra-procedural outcomes and success of implantation in patients undergoing left atrial appendage occlusion will be assessed.

Eligibility criteria: Inclusion Criteria:

* Male/Females
* Age:18-80 years
* History of Atrial Fibrillation/Atrial flutter
* Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device

Exclusion Criteria:

* Inability or unwillingness of an individual to give written informed consent
* Patient not following with our practice after the procedure
* Complex anatomy for endocardial LAAC
* Thrombus in LAA
* Patients with pericardial effusion in pre-op TEE/CCTA
* Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)

Primary outcomes:
measure: Success of Implantation of Left Atrial Appendage Closure (LAAC) device
timeFrame: 1 Day
Secondary outcomes:
measure: Intraprocedural measurements
timeFrame: 1 Day
measure: Intraprocedural measurements
timeFrame: 1 Day
measure: Intraprocedural measurements - LAA device size
timeFrame: 1 Day
measure: Location of the leaks
timeFrame: 1 Day
measure: Intraprocedural measurements
timeFrame: 1 Day
Other outcomes:
measure: Post Procedural Outcomes
timeFrame: 45 Days, 6 Months and 12 Months
measure: Post Procedural Outcomes - Size of the leaks
timeFrame: 45 Days, 6 Months and 12 Months
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute - Roe Clinic
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9. doi: 10.1161/01.cir.0000015698.54752.6d.
citation: Saw J. Intracardiac Echocardiography for Endovascular Left Atrial Appendage Closure: Is it Ready for Primetime? JACC Cardiovasc Interv. 2017 Nov 13;10(21):2207-2210. doi: 10.1016/j.jcin.2017.07.002. Epub 2017 Aug 30. No abstract available.
citation: Khalili H, Patton M, Taii HA, Bansal P, Brady M, Taylor J, Gurung A, Maini B. 4D Volume Intracardiac Echocardiography for Intraprocedural Guidance of Transcatheter Left Atrial Appendage Closure. J Atr Fibrillation. 2019 Dec 31;12(4):2200. doi: 10.4022/jafib.2200. eCollection 2019 Dec.
citation: Ranard LS, Khalique OK, Donald E, Agarwal V, Hamid N, Hahn RT, Ng V, Brady M, Gurung A, Ali ZA, Leon MB, Sommer R, Vahl TP. Transcatheter Left Atrial Appendage Closure Using Preprocedural Computed Tomography and Intraprocedural 4-Dimensional Intracardiac Echocardiography. Circ Cardiovasc Interv. 2021 Jul;14(7):e010686. doi: 10.1161/CIRCINTERVENTIONS.121.010686. Epub 2021 Jun 23. No abstract available.
citation: http://cardiacvascularnews.com/nuvera-announces-successful-first-in-human-use-of-nuvision-ice-catheter/