4D Intracardiac Echocardiography for Atrial Fibrillation
Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures
Recruiting
N/AInterventional Study
Atrial Fibrillation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
20 (estimated)
Sponsor
The Cleveland Clinic · Other
Who this trial is looking for
This trial is looking for adults who are scheduled for a specific heart procedure. Participants will help test a new imaging technology during the procedure.
Are You a Good Fit for This Trial?
Rules you outSepsisCerebral ischemic eventDeep vein thrombosis
You may be able to join if
I am over 18 years old
I am scheduled for a LAAO transcatheter procedure
I can give informed consent
I will have ablation before the LAAO procedure if applicable
You may not be able to join if
I am currently in another clinical study
I have a bleeding disorder
I have a vascular problem that makes catheterization impossible
I have a blood clot in my heart
I had a heart attack in the past two months
I have severe heart failure or angina
I have an active infection
I have a weakened immune system
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 (…
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.
Trial Locations
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Status
Eligibility Criteria
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…
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
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