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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Device: Imaging guidance with TEE and ICE for Left atrial appendage closure

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donita Atkins; Phone Number: 816-651-1969; Email: Datkins@kchrf.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • Kansas City Heart Rhythm Institute - Roe Clinic
      • Principal Investigator: Dhanunjaya Lakkireddy, MD
      • Contact: Donita Atkins; Phone Number: 816-651-1969; Email: Datkins@kchrf.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - TEE Primary imaging guidance; TEE is the primary imaging guidance with 4D ICE is the secondary	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.
Experimental: Arm 2 - ICE Primary Imaging Guidance; 4D ICE is the primary imaging guidance and TEE is the secondary	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of Implantation of Left Atrial Appendage Closure (LAAC) device	Success of Implantation of Amulet or Watchman FLX device	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Intraprocedural measurements	LAA size in different sites will be noted from Echocardiograms	1 Day
Intraprocedural measurements - LAA device size	LAA device size will be measured based on the LAA size	1 Day
Location of the leaks	Location of the leaks will be identified	1 Day
Intraprocedural measurements	Procedural duration, Fluoroscopic time	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Post Procedural Outcomes - Size of the leaks	Leaks if any, leaks size will be measured	45 Days, 6 Months and 12 Months

Collaborators and Investigators

• Sponsor: Kansas City Heart Rhythm Research Foundation
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KCHRRF_Nuvision ICE_0017

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