Actively Recruiting
The Role of Multimodality Imaging in Left Atrial Appendage Closure
Led by Hungarian Institute of Cardiology · Updated on 2024-10-22
44
Participants Needed
1
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging. According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging. Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (PDL, device thrombi).
CONDITIONS
Official Title
The Role of Multimodality Imaging in Left Atrial Appendage Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a clinical indication for percutaneous left atrial appendage closure at Gottsegen National Cardiovascular Center between 10.03.2021 and 31.12.2025
- Age above 18 years
- Provided informed consent
- Have legal capacity
You will not qualify if you...
- Age under 18 years
- Pregnancy
- Incapacitation
- No consent given
- Esophageal stenosis or diverticulum
- Active esophageal bleeding
- Allergy to CT contrast agent
- Severe chronic kidney disease with GFR less than 15 ml/min/1.73 m2
- Presence of appendage thrombus with significant embolic risk
- Life expectancy shorter than 12 months
- Active infection
- Significant mitral valve stenosis
- Mechanical heart valve
- Indication for open heart surgery
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)
Budapest, Hungary, 1096
Actively Recruiting
Research Team
P
Peter Andreka, MD, PhD
CONTACT
G
Geza Fontos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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