Applause Study I - Append System Early Feasibility Study

NCT07278869 | Recruiting DMC FDA Device

• 1 other identifier: CLD-000001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non Valvular Atrial Fibrillation

Keywords

Left Atrial Appendage (LAA)

Outcome Measures

Primary Outcomes (1)

• Composite major adverse events

  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

  30 days

Secondary Outcomes (2)

• Composite major adverse events

  6 months

• Procedure and Technical Success

  30 days

Study Arms (1)

Append System

EXPERIMENTAL

Elimination of the left atrial appendage (LAA) using the Append System through a transcatheter procedure that invaginates and ligates the LAA tissue.

Device: Left Atrial Appendage Elimination: Append System

Interventions

Left Atrial Appendage Elimination: Append System DEVICE

Elimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue.

Append System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female aged ≥18 years
• Documented non-valvular AF (paroxysmal, persistent, permanent or non-rheumatic valve-related AF)
• The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
• The subject is eligible for the defined protocol medication regimen of anticoagulation and antiplatelet therapy following Append procedure.
• The patient is deemed appropriate for LAA ligation by the screening committee and the investigator.
• The patient has been informed of the nature of the study, agrees to its provisions \& follow-up evaluations, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

You may not qualify if:

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
• Atrial fibrillation that is defined by a single occurrence or that is considered to be reversible (e.g., due to thyroid disorders, acute alcohol intoxication, trauma, or recent major surgical procedures).
• Patients with an indication for chronic oral anticoagulation other than AF (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
• Clinically significant Severe heart failure (New York Heart Association functional class IV)
• Prior cardiac surgery or surgery requiring sternotomy
• Recent (within 3 months pre-procedure) stroke or transient ischemic attack.
• Recent (within 3 months pre-procedure) myocardial infarction
• Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) cardiac interventional procedures (e.g., percutaneous coronary intervention, structural heart valve procedures, etc.)
• Planned (within 60 days after the index procedure) cardiac surgical procedures or any surgeries which require sternotomy.
• Recent (within 30 days before the index procedure) or planned (within 60 days after the index procedure) noncardiac procedures or surgical interventions.
• History of symptomatic pericarditis (acute or chronic).
• Patient has evidence of cardiac tumor
• Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation), or dialysis at the time of screening
• Platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3 or known Bleeding diathesis
• Active infection with bacteremia

Sponsors & Collaborators

• Append Medical Ltd.: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Study Officials

• Vivek Reddy, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liz Zinger, MSc

CONTACT

+972-50-2071741; liz.zinger@appendmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Not applicable - open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm study in which all enrolled participants receive the Append System procedure

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 12, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)