New York, NYNCT07278869Now EnrollingIRB Ready

Non Valvular Atrial Fibrillation Clinical Trial in New York, NY

Access cutting-edge non valvular atrial fibrillation treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Append Medical Ltd.

Quick Self-Assessment

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Expert Care in New York

Access non valvular atrial fibrillation specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related non valvular atrial fibrillation treatment provided free

Apply for This New York Location

Check if you qualify for this non valvular atrial fibrillation clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Non Valvular Atrial Fibrillation Study in New York

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.

Sponsor: Append Medical Ltd.

Who Can Participate

Inclusion Criteria

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). 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07278869) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non Valvular Atrial Fibrillation Treatment Options in New York, NY

If you're searching for non valvular atrial fibrillation treatment options in New York, NY, this clinical trial (NCT07278869) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non valvular atrial fibrillation specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non valvular atrial fibrillation clinical trials near you to find additional studies recruiting in your area.

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