Atrial Fibrillation study: 4D ICE Adjunct Imaging
Official title Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures
ClinicalTrials.gov ID: NCT07806890
What this study is testing
- What it's testing
- The study looks at how well the new 4‑D ICE catheter images the heart and whether it is safe to use during procedures, compared with the usual trans‑esophageal echocardiogram (TEE).
- Who it's for
- Adults who have atrial fibrillation and are having a heart rhythm or structural heart procedure.
- What's involved
- Participants will receive the standard care with a Watchman device and a TEE. The new ICE catheter will be used only for research imaging and to study workflow; it does not change the treatment plan.
- Time commitment
- The study lasts for the duration of the procedure, with no extra visits required beyond the normal care appointments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- people who are currently enrolled in any other investigational clinical studies
- people with any bleeding diathesis
- people with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
- people with known intracardiac thrombus
- people with myocardial infarction within the prior two months
- people with class IV angina or heart failure
See the full eligibility criteria
- 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
- people who are currently enrolled in any other investigational clinical studies
- people with any bleeding diathesis
- people with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
- people with known intracardiac thrombus
- people with myocardial infarction within the prior two months
- people with class IV angina or heart failure
- people with sepsis or active infection
- people with immune-deficiency or immune-compromised status
- people with cerebral ischemic event in the prior six months
- people with deep vein thrombosis
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.