4D-ICE Imaging for Atrial Fibrillation Treatment
Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure
Recruiting
N/A
Interventional Study
Atrial Fibrillation
Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 52 (estimated)
- Sponsor
- Kansas City Heart Rhythm Research Foundation · Other
Who this trial is looking for
This trial is looking for adults who have atrial fibrillation and are undergoing a specific heart procedure. Participants will have imaging done to help with the procedure and will be followed for 12 months.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 18 and 80 years old
- I have a history of atrial fibrillation or atrial flutter
- I will have a Left Atrial Appendage Closure with an Amplatzer Amulet or WATCHMAN FLX device
You may not be able to join if
- I am unable or unwilling to give written consent
- I am not following up with my doctor after the procedure
- I have complex anatomy for the procedure
- I have a blood clot in my Left Atrial Appendage
- I have fluid around my heart before the procedure
- I am currently pregnant
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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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 at…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Inability or unwillingness of an individual to give written infor…
Contacts