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New treatment option for Non Valvular Atrial Fibrillation
Official title Applause Study I - Append System Early Feasibility Study
ClinicalTrials.gov ID: NCT07278869
What this study is testing
- What it's testing
- 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.
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- Atrial fibrillation that is defined by a single occurrence or that is considered to be reversible (e.g., due to thyroid disorders, acute alcohol...
- Patients with an indication for chronic oral anticoagulation other than AF (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism...
- 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.
See the full eligibility criteria
Who can 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...
What rules you out
- 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)...
- 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 treatment 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 \ 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...
- 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...
- LAA structure that in the opinion of the screening committee / investigator precludes intervention
The study team makes the final eligibility decision.
Where it's taking place
- Jonesboro, Arkansas, United States
- Los Angeles, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jonesboro, Arkansas, United States; Los Angeles, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.