Append System for Atrial Fibrillation
(Applause Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method called the Append System to treat atrial fibrillation (AF), a heart condition that causes an irregular heartbeat. The goal is to determine if it is safe and effective to remove a small part of the heart called the left atrial appendage, which may help prevent blood clots. This procedure uses a thin tube inserted into the body, known as a transcatheter procedure. Individuals with non-valvular atrial fibrillation who are eligible for certain blood-thinning medications might be suitable candidates for this trial.
As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments for AF.
What prior data suggests that the Append System is safe for eliminating the left atrial appendage?
Research has shown that the Append System, used to remove the left atrial appendage (LAA) from the heart, appears safe based on earlier studies. For instance, one study found that using a device to close off the LAA did not cause major problems, indicating the procedure was performed without significant safety issues. Another study demonstrated that combining this procedure with another heart treatment was both safe and effective.
Overall, these findings suggest that treatments involving the LAA can be performed with minimal risk when conducted by experienced medical teams. However, the Append System is still undergoing testing to further confirm its safety. Participants should discuss any concerns with their doctors before joining a trial.12345Why are researchers excited about this trial?
Most treatments for atrial fibrillation focus on managing heart rate, rhythm, or thinning the blood to prevent clots, such as anticoagulants or catheter ablation. However, the Append System is unique because it physically eliminates the left atrial appendage (LAA) using a transcatheter procedure. This approach invaginates and ligates the LAA tissue, which could reduce stroke risk without the need for lifelong medication. Researchers are excited about this treatment because it offers a potentially safer and more permanent solution to a common complication of atrial fibrillation, using a minimally invasive method.
What evidence suggests that the Append System is effective for atrial fibrillation?
Research has shown that removing or closing the left atrial appendage (LAA) can reduce the risk of stroke in people with atrial fibrillation. One study found that closing the LAA resulted in a 5.3% chance of death, stroke, or blood clots over three years, which is promising compared to other treatments. Another study confirmed that closing the LAA after certain procedures helps prevent strokes and other serious issues. This trial tests the Append System as an experimental treatment designed to remove the LAA using a less invasive method, potentially offering a safer and more effective option for patients. Overall, these findings suggest that managing atrial fibrillation can improve by removing or closing the LAA.678910
Who Is on the Research Team?
Vivek Reddy, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Participants undergo the Append System procedure to eliminate the left atrial appendage (LAA) through invagination and ligation
Initial Follow-up
Participants are monitored for procedure and technical success, and early adverse events
Extended Follow-up
Participants are monitored for long-term safety, device performance, and major adverse events
Long-term Follow-up
Participants are followed for up to 5 years to assess long-term outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Append System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Elimination of the left atrial appendage (LAA) using the Append System through a transcatheter procedure that invaginates and ligates the LAA tissue.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Append Medical Ltd.
Lead Sponsor
Citations
Outcomes of Concomitant Atrial Fibrillation Ablation and Left ...
The mean CHA2DS2VASc and HAS-BLED scores were 4.0 ± 1.4 and 2.8 ± 1.1, respectively. Pulmonary vein isolation was achieved in all patients. LAAC ...
Pulsed Field Ablation of Persistent Atrial Fibrillation With ...
A, The prespecified atrial flutter effectiveness end-point rate was 96.4% in the 141-patient cohort. In addition, both the primary safety (B) ...
Left Atrial Appendage Closure after Ablation for ...
The primary efficacy end point, tested for noninferiority, was a composite of death from any cause, stroke, or systemic embolism at 36 months.
Pulsed Field Ablation for Persistent Atrial Fibrillation
Primary effectiveness was 63.5% (57.3% lower confidence limit) at 1 year, with 8.5% patients having a single, isolated atrial fibrillation ...
Improving outcomes of atrial fibrillation ablation by integrated ...
The POP-AF trial is the first randomized controlled trial to investigate the efficacy of a comprehensive integrated, nurse-led, lifestyle intervention on ...
Safety and feasibility of atrial fibrillation ablation after left atrial ...
Atrial fibrillation ablation in the presence of an LAAC device implanted including the early phase was safe and feasible without LAAC device adverse events.
Outcomes of Concomitant Atrial Fibrillation Ablation and ...
The purpose of this study was to assess the safety and efficacy of combining AF ablation and LAAC in a single procedure.
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news.bostonscientific.com
news.bostonscientific.com/2026-03-28-CHAMPION-AF-study-of-the-WATCHMAN-FLX-TM-Left-Atrial-Appendage-Closure-Device-as-a-first-line-therapy-for-stroke-risk-reduction-meets-all-primary-and-secondary-safety-and-efficacy-endpointsCHAMPION-AF study of the WATCHMAN FLX™ Left Atrial ...
The primary safety endpoint was met with data demonstrating the WATCHMAN FLX device was statistically superior to NOACs (10.9% vs. 19.0%; P< ...
A report from the NCDR AFib Ablation Registry
A total of 70,296 first-time AF ablations at 186 US hospitals were included. Overall, procedural success and MAE rates were 98.5% and 1.0%, respectively. With ...
Safety of Percutaneous Left Atrial Appendage Closure
Thus, these data indicate that with experience, it is possible to implant the device with minimal risk of procedure-related stroke. Similarly, ...
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