Early Study of the Append System for Atrial Fibrillation
This early study is looking at the safety and how well a new device, called the Append System, works for people with non-valvular atrial fibrillation (an irregular heartbeat not caused by a heart valve problem). The Append System aims to close off a small pouch in the heart called the left atrial appendage (LAA), which can be a source of blood clots. The procedure involves a catheter (a thin tube) to invaginate and ligate (tie off) the LAA tissue. We are looking for people aged 18 or older with non-valvular AF and a CHA2DS2-VASc score of 2 or higher for males, or 3 or higher for females. The main goal is to see if there are any major problems within 30 days after the procedure. The study is currently unclear on its recruitment status and plans to enroll 15 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is an early feasibility study, and 15 participants are planned.
- What's involved
- Patients will be followed for up to 5 years after the procedure to check on safety and how well the device works.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after the procedure.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Applause Study I - Append System Early Feasibility Study
At a glance
Conditions
NCT07278869
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Arrhythmia Research Group
Jonesboro, Arkansasno site contact published
Recruiting
Cedars-Sinai Medical Center
Los Angeles, Californiano site contact published
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New Yorkno site contact published
Recruiting
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
- Vivek Reddy, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Composite major adverse events30 days
Composite rate of major adverse events related to the device or procedure, including all-cause mortality, ischemic stroke, systemic embolism, and cardiac tamponade or pericardial effusion requiring drainage