Recruiting

4D ICE

Sponsor:

The Cleveland Clinic

Code:

NCT07806890

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

4D ICE Adjunct Imaging

Study Details

Brief summary:

The purpose of this study is to evaluate the imaging performance and procedural safety of a prototype 4D ICE catheter during real-time intracardiac imaging and to optimize device imaging parameters, compared with current standard imaging modalities.

TEE is the current standard of care and will serve as the primary imaging modality for clinical guidance during the EP and Structural Heart Disease (SHD) procedures. In this research protocol, TEE is not being investigated. ICE will be used as an adjunct imaging modality for research data collection and workflow evaluation only. All procedures will be performed using commercially available, FDA-approved Watchman devices, and no investigational implantable devices will be used. The use of ICE in this study does not modify the approved therapeutic device indication, implantation technique, or standard clinical decision-making.

Conditions

Atrial Fibrillation

Study ID

NCT07806890

Start date

Aug 7, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Be aged above 18 for adult participants
2. Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
3. Be able and willing to give informed consent
4. (For concomitant cases only) Ablation will occur prior to LAAO implantation

Exclusion Criteria:

Potential subjects must not include:

1. Subjects who are currently enrolled in any other investigational clinical studies
2. Subjects with any bleeding diathesis
3. Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
4. Subjects with known intracardiac thrombus
5. Subjects with myocardial infarction within the prior two months
6. Subjects with class IV angina or heart failure
7. Subjects with sepsis or active infection
8. Subjects with immune-deficiency or immune-compromised status
9. Subjects with cerebral ischemic event in the prior six months
10. Subjects with deep vein thrombosis

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 4D ICE Adjunct Imaging

Participants undergoing left atrial appendage occlusion (LAAO) procedures (with or without concomitant electrophysiology procedures) will receive adjunctive imaging using the 4D ICE catheter while TEE remains the primary imaging modality for procedural guidance.

Interventions

4D ICE Adjunct Imaging

Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.

Primary outcome measure

  • Feasibility of 4D ICE Imaging Performance [ Time Frame: During the Procedure ]

Central Contacts and Locations

Central contacts

Walid Saliba, MD

216-444-6810salibaw@ccf.org

Locations

Cleveland Clinical Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Walid Saliba, MD

216-444-6810salibaw@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Sep 8, 2026

Last verified

Aug, 2026

Keywords

  • A-Fib
  • Left Atrial Appendate Occlusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-09-08.