NCT07806890Recruiting
Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures
Assessment of Utility of Siemens Healthineers 4D ICE and Premium CV System Workflow in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Procedures
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 7 Aug 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Atrial fibrillation
- NCT number
- NCT07806890
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 7 Aug 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with myocardial infarction within the prior two months
- Subjects with cerebral ischemic event in the prior six months
Other illness
- Subjects with any bleeding diathesis
- Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
- Subjects with class IV angina or heart failure
- Subjects with sepsis or active infection
- Subjects with deep vein thrombosis
Other
- Potential subjects must not include:
- Subjects who are currently enrolled in any other investigational clinical studies
- Subjects with known intracardiac thrombus
- Subjects with immune-deficiency or immune-compromised status
Who the study is looking for
- Be aged above 18 for adult participants
- Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
- Be able and willing to give informed consent
- (For concomitant cases only) Ablation will occur prior to LAAO implantation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinical Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.