Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial.
Vivek Y Reddy, Horst Sievert, Jonathan Halperin...
https://pubmed.ncbi.nlm.nih.gov/25399274Actively Recruiting
Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID06348394
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
Led by Baylor Research Institute · Updated on 2026-04-15
444
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using Intracardiac echocardiography (ICE) compared to the traditional Transesophageal echocardiography (TEE) to guide Left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation. This study aims to assess how well ICE works for implanting LAAC devices by measuring procedural success and complications. It also looks at procedural details like duration, fluoroscopy time, and hospital stay, along with patient satisfaction. Participants will be randomly assigned to receive LAAC device implantation guided either by Intracardiac echocardiography performed before the procedure or by Transesophageal echocardiography performed under general anesthesia. The study is conducted at a single center and compares the two imaging methods to understand differences in safety, effectiveness, and patient experience during and after the procedure. During the study, researchers will monitor procedural success during the operation and follow participants for 45 days afterward to track complications such as stroke or device issues, procedural details, hospital costs, and patient satisfaction. Participants will undergo imaging like CT or TEE before the procedure. The total duration of participation includes the procedure and a 45-day follow-up period to assess outcomes and safety.
CONDITIONS
Brief Title
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with non-valvular atrial fibrillation (paroxysmal, persistent, or permanent)
- High risk of stroke or systemic embolism with CHADS2 score 2 or CHA2DS2-VASc score 3
- Suitable for oral anticoagulation with warfarin or DOAC and seeking a nonpharmacologic alternative
- Able to undergo pre-procedural imaging with CT or transesophageal echocardiography
- Able to comply with the study protocol
- Provide written informed consent before participation
- Aged 18 years or older
You will not qualify if you...
- Presence of intracardiac thrombus on preprocedural imaging (TEE or CT)
- History of previously implanted atrial septal defect or patent foramen ovale device
- Severe left ventricular dysfunction (EF < 40%) or more than moderate valvular heart disease
- Enrollment in another conflicting study without approval
- Poor clinical condition such as cardiogenic shock prohibiting function tests
- Planned cardiac intervention from consent up to 60 days post-procedure
- Any condition posing significant hazard as judged by investigator
- Pregnant, breastfeeding, or planning pregnancy during the study
- Children under 18 years, prisoners, or unable to provide consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Procedure day
Participants undergo left atrial appendage closure guided by either intracardiac or transesophageal echocardiography.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 45 days
Participants are monitored for complications, procedural outcomes, and satisfaction after the procedure.
Follow-up visits during 45 days after procedure
Trial Site Locations
Total: 1 location
1
Baylor Scott and White Heart Hospital
Plano, Texas, United States, 75093
Actively Recruiting
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Research Team
B
Bonnie Ostergren
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Left atrial appendage closure with the Watchman device using intracardiac vs transesophageal echocardiography: Procedural and cost considerations.
Majd E Hemam, Kenji Kuroki, Paul A Schurmann...
https://pubmed.ncbi.nlm.nih.gov/30827462Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies.
Apostolos Tzikas, David R Holmes, Sameer Gafoor...
https://pubmed.ncbi.nlm.nih.gov/27540038