Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07278869

Applause Study I - Append System Early Feasibility Study

Led by Append Medical Ltd. · Updated on 2026-05-01

15

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This early feasibility study is intended to evaluate the safety and feasibility of the Append System for eliminating the left atrial appendage (LAA) through a transcatheter procedure that invaginates and ligates the LAA tissue.

CONDITIONS

Official Title

Applause Study I - Append System Early Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or non-pregnant female aged 18 years or older
  • Documented non-valvular atrial fibrillation (paroxysmal, persistent, permanent, or non-rheumatic valve-related)
  • CHA2DS2-VASc score of 2 or greater for males, or 3 or greater for females
  • Eligible for anticoagulation and antiplatelet therapy after the Append procedure
  • Deemed appropriate for LAA ligation by screening committee and investigator
  • Provided informed consent approved by Institutional Review Board or Ethics Committee
Not Eligible

You will not qualify if you...

  • Pregnant or nursing women or planning pregnancy within 1 year after the procedure; females of childbearing potential must have a negative pregnancy test within 7 days before procedure
  • Atrial fibrillation due to reversible causes or a single occurrence
  • Need for chronic oral anticoagulation for reasons other than atrial fibrillation
  • Severe heart failure (NYHA class IV)
  • Prior cardiac surgery requiring sternotomy
  • Stroke or transient ischemic attack within 3 months before procedure
  • Myocardial infarction within 3 months before procedure
  • Cardiac interventional procedures within 30 days before or planned within 60 days after procedure
  • Cardiac surgery or sternotomy planned within 60 days after procedure
  • Noncardiac procedures or surgeries within 30 days before or planned within 60 days after procedure
  • History of symptomatic pericarditis
  • Evidence of cardiac tumor
  • Renal insufficiency with eGFR less than 30 mL/min/1.73 m2 or dialysis at screening
  • Abnormal platelet or white blood cell counts, or known bleeding disorders
  • Active infection with bacteremia
  • Allergies or contraindications to aspirin, heparin, or P2Y12 inhibitors, or contrast sensitivity that cannot be pre-medicated
  • Participation in another investigational drug or device study interfering with this study
  • Unable to undergo general anesthesia
  • Conditions preventing adequate transesophageal echocardiography or computed tomography assessment
  • Other medical illness or substance abuse causing non-compliance or life expectancy under 5 years
  • Intracardiac thrombus at screening
  • Left ventricular ejection fraction below 30%
  • Large pericardial effusion or signs of pericarditis or tamponade
  • Inter-atrial septum to LAA ostium distance less than 40 mm
  • Anatomy or prior interventions preventing transseptal approach
  • LAA anatomy precluding intervention as judged by screening committee or investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

L

Liz Zinger, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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