Comparing Steerable Sheaths for Left Atrial Appendage Closure
This study is looking at how a new, steerable delivery sheath compares to a traditional, non-steerable sheath when closing the left atrial appendage (LAA) with the Amplatzer™ Amulet™ device. The LAA is a small pouch in the heart where blood clots can form, leading to stroke in people with atrial fibrillation (an irregular heartbeat). Researchers want to see if the steerable sheath helps achieve better closure of the LAA. You may be able to join if you have atrial fibrillation and are scheduled to have your LAA closed with the Amplatzer™ Amulet™ device. The study will measure how many people achieve immediate closure of the LAA, and look for complications like heart perforation (a small hole in the heart) or the need for pericardiocentesis (a procedure to remove fluid around the heart) within 7 days. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 300 participants. It compares two different types of sheaths used during the LAA closure procedure.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for acute closure of the LAA at 1 day, and for cardiac perforation and need for pericardiocentesis at 7 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Steerable Delivery Sheaths on Successful Closure of LA A With AMULET
At a glance
Conditions
NCT05464511
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Centerpoint Medical Center
Independence, Missourino site contact published
Centerpoint Medical Center Clinic
Independence, Missourino site contact published
Kansas City Heart Rhythm Institute
Overland Park, Kansasno site contact published
Menorah Medical Center
Overland Park, Kansasno site contact published
Overland Park Regional Medical Center
Overland Park, Kansasno site contact published
Research Medical Center
Kansas City, Missourino site contact published
Research Medical Center Clinic
Kansas City, Missourino site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Dhanunjaya Lakkireddy · PRINCIPAL_INVESTIGATOR · Kansas City Heart Rhythm Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Exclusion
What this trial measures
- Number of participants with Acute Closure of Left Atrial Appendage1 day
Acute closure ( less than or equal to 3mm) of the left atrial appendage after Left Atrial Appedage Occlusion(LAAO) procedure
- Number of patients with Cardiac Perforation7 days
Number of patients with cardiac perforation
- Need for Pericardiocentesis7 days
Need for pericardiocentesis within 7 days of implantation