Non Valvular Atrial FibrillationApplauseNCT07278869
Applause Study I - Append System Early Feasibility Study
A study testing Left Atrial Appendage Elimination: Append System in people with Non Valvular Atrial Fibrillation, run by Append Medical Ltd. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Valvular Atrial Fibrillation
- What is being tested?
- Left Atrial Appendage Elimination: Append System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2026to Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- General Exclusion Criteria:
- 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
- Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated
- Current participation in another investigational drug or device study that would interfere with this study
- Patient is unable to undergo general anesthesia
- Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) or computed tomographic (CT) assessment.
- Known other medical illness or known history of substance abuse that may cause non-compliance with the specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years.
- Cardiac Imaging Exclusion Criteria:
- Intracardiac thrombus observed during screening
- Left ventricular ejection fraction (LVEF) <30%
- Circumferential pericardial effusion >5 mm or signs / symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
- Distance from inter-atrial septum fossa ovalis to LAA ostium is less than 40 mm
- Any anatomy or prior intervention that would preclude a transseptal approach (including, but not limited to, prior IVC filter placement that cannot be crossed, prior ASD, or prior PFO closure device implantation that precludes transseptal puncture)
- LAA structure that in the opinion of the screening committee / investigator precludes intervention
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation
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.
Read the detailed description
The objective of this study is to evaluate the safety and performance of the Append System in patients with non-valvular atrial fibrillation who are considered appropriate candidates for LAA closure to reduce the risk of thromboembolism originating from the LAA.
The Append System is designed to eliminate the LAA without the use of a permanent metallic implant. The procedure is performed via a transfemoral, transseptal, transcatheter approach. During the procedure, the LAA is invaginated into the left atrium (LA), and the inverted tissue is ligated using a standard surgical suture, resulting in elimination of the LAA cavity.
Patients will be followed for up to 5 years after the procedure to assess safety, device performance, and long-term outcomes.
- Conditions
- Non Valvular Atrial Fibrillation
- Being tested
- Left Atrial Appendage Elimination: Append System
- Keywords
- Left Atrial Appendage (LAA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage Elimination: Append SystemDevice
Elimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Left Atrial Appendage Elimination: Append System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
Composite major adverse events
Composite rate of major adverse events related to the device or procedure, including all-cause mortality, ischemic stroke, systemic embolism, pericardial effusion requiring drainage, major bleeding (BARC 3/ BARC 5), hemorrhagic stroke, and device or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair
Measured: 6 months
Procedure and Technical Success
LAA cavity elimination by LAA invagination and ligation with invagination proximal to the LAA ostium and lack of fluid communication between the LA and LAA- observed by TEE
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start29 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Valvular Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study in which all enrolled participants receive the Append System procedure
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Append Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vivek Reddy, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278869
- Sponsor's protocol ID
- CLD-000001
- Acronym
- Applause
- Status last verified
- May 2026
- First submitted
- 3 Dec 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared. The study is an early feasibility investigation conducted under an FDA IDE, and the data will be retained by the sponsor and reported in aggregate only.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation
- ClinicalTrials.gov ID
- NCT07278869
- Acronym / sponsor ID
- Applause / CLD-000001
- Conditions
- Non Valvular Atrial Fibrillation
- Keywords
- Left Atrial Appendage (LAA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Append Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to evaluate the safety and performance of the Append System in patients with non-valvular atrial fibrillation who are considered appropriate candidates for LAA closure to reduce the risk of thromboembolism originating from the LAA.
The Append System is designed to eliminate the LAA without the use of a permanent metallic implant. The procedure is performed via a transfemoral, transseptal, transcatheter approach. During the procedure, the LAA is invaginated into the left atrium (LA), and the inverted tissue is ligated using a standard surgical suture, resulting in elimination of the LAA cavity.
Patients will be followed for up to 5 years after the procedure to assess safety, device performance, and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study in which all enrolled participants receive the Append System procedure
| Arm | Type | Receives |
|---|---|---|
| Append System | Experimental | Device: Left Atrial Appendage Elimination: Append SystemElimination of the left atrial appendage (LAA) using the Append System through a transcatheter procedure that invaginates and ligates the LAA tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage Elimination: Append SystemElimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue. | Device | Append System |
Primary outcome
Composite major adverse events
Time frame: 30 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
2 secondary outcomes
Composite major adverse events
Time frame: 6 months
Procedure and Technical Success
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The study is an early feasibility investigation conducted under an FDA IDE, and the data will be retained by the sponsor and reported in aggregate only.
Related trials for Non Valvular Atrial Fibrillation
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An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
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CHAMPION-AF Clinical Trial
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Vortosiran in Atrial Fibrillation
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WATCHMAN FLX Pro European Registry
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LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vivek Reddy, MD principal investigator
Icahn School of Medicine at Mount Sinai
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Atrial Appendage Elimination: Append System in people with Non Valvular Atrial Fibrillation, run by Append Medical Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liz Zinger, MSc (+972-50-2071741, liz.zinger@appendmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite major adverse events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.