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)
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started May 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2023
CompletedFirst Submitted
Initial submission to the registry
September 11, 2023
CompletedFirst Posted
Study publicly available on registry
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedAugust 28, 2025
October 1, 2024
2.6 years
September 11, 2023
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Success of Implantation of Left Atrial Appendage Closure (LAAC) device
Success of Implantation of Amulet or Watchman FLX device
1 Day
Secondary Outcomes (5)
Intraprocedural measurements
1 Day
Intraprocedural measurements
1 Day
Intraprocedural measurements - LAA device size
1 Day
Location of the leaks
1 Day
Intraprocedural measurements
1 Day
Other Outcomes (2)
Post Procedural Outcomes
45 Days, 6 Months and 12 Months
Post Procedural Outcomes - Size of the leaks
45 Days, 6 Months and 12 Months
Study Arms (2)
Arm 1 - TEE Primary imaging guidance
EXPERIMENTALTEE is the primary imaging guidance with 4D ICE is the secondary
Arm 2 - ICE Primary Imaging Guidance
EXPERIMENTAL4D ICE is the primary imaging guidance and TEE is the secondary
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211, United States
Related Publications (5)
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.
PMID: 11997272BACKGROUNDSaw 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.
PMID: 28866032BACKGROUNDKhalili 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.
PMID: 32435343BACKGROUNDRanard 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.
PMID: 34157847BACKGROUNDhttp://cardiacvascularnews.com/nuvera-announces-successful-first-in-human-use-of-nuvision-ice-catheter/
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dhanunjaya Lakkireddy, MD
Kansas City Heart Rhythm Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2023
First Posted
September 29, 2023
Study Start
May 10, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
August 28, 2025
Record last verified: 2024-10