Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

Stroke Clinical Trial

Official title:

Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061757
• Other study ID #: KCHRRF_Nuvision ICE_0017
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Device:
• Imaging guidance with TEE and ICE for Left atrial appendage closure
The occluder size for both LAAC devices will be selected based on the maximal diameter of the LAA orifice following the manufacturer guidelines and using the maximal length of the LAA measured on Echocardiogram. Intraprocedural measurements of the LAA width and depth were acquired on both ICE and TEE per protocol. Both ICE and TEE will be used to assess for any procedural complications prior to insertion of the device delivery sheath.

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute - Roe Clinic	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (5)

http://cardiacvascularnews.com/nuvera-announces-successful-first-in-human-use-of-nuvision-ice-catheter/

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post Procedural Outcomes	Presence of any Peri-device leaks (PDL), Device Related Thrombus (DRTs), Micro migration and device tilt will be noted.	45 Days, 6 Months and 12 Months
Other	Post Procedural Outcomes - Size of the leaks	Leaks if any, leaks size will be measured	45 Days, 6 Months and 12 Months
Primary	Success of Implantation of Left Atrial Appendage Closure (LAAC) device	Success of Implantation of Amulet or Watchman FLX device	1 Day
Secondary	Intraprocedural measurements	Transeptal access view, LAA thrombus, Stability of the device, Peri-device leaks, Device Repositioning, Clarity of mitral valve or pulmonary vein impingement will be noted as Yes/No from Echocardiogram	1 Day
Secondary	Intraprocedural measurements	LAA size in different sites will be noted from Echocardiograms	1 Day
Secondary	Intraprocedural measurements - LAA device size	LAA device size will be measured based on the LAA size	1 Day
Secondary	Location of the leaks	Location of the leaks will be identified	1 Day
Secondary	Intraprocedural measurements	Procedural duration, Fluoroscopic time	1 Day