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NCT Number: NCT06061757

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

Location status: Recruiting

Location contact

Dhanunjaya Lakkireddy, MD

PRINCIPAL_INVESTIGATOR

Donita Atkins

CONTACT

[email protected]

816-651-1969

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Imaging guidance with TEE and ICE for Left atrial appendage closure

Device

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.

Primary outcomes

  1. Success of Implantation of Left Atrial Appendage Closure (LAAC) device

    Time frame: 1 Day

    Success of Implantation of Amulet or Watchman FLX device

Secondary outcomes

  1. Intraprocedural measurements

    Time frame: 1 Day

    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

  2. Intraprocedural measurements

    Time frame: 1 Day

    LAA size in different sites will be noted from Echocardiograms

  3. Intraprocedural measurements - LAA device size

    Time frame: 1 Day

    LAA device size will be measured based on the LAA size

  4. Location of the leaks

    Time frame: 1 Day

    Location of the leaks will be identified

  5. Intraprocedural measurements

    Time frame: 1 Day

    Procedural duration, Fluoroscopic time

Other outcomes

  1. Post Procedural Outcomes

    Time frame: 45 Days, 6 Months and 12 Months

    Presence of any Peri-device leaks (PDL), Device Related Thrombus (DRTs), Micro migration and device tilt will be noted.

  2. Post Procedural Outcomes - Size of the leaks

    Time frame: 45 Days, 6 Months and 12 Months

    Leaks if any, leaks size will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Donita Atkins

CONTACT

[email protected]

816-651-1969

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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