NCT07278869Toboroz
Applause Study I - Append System Early Feasibility Study
Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 27.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 15 (tervezett)
- Első benyújtás
- 2025. dec. 3.
- Kezdés
- 2026. ápr. 29.
- Elsődleges befejezés
- 2027. szept.
- Fő szponzor
- Append Medical Ltd.
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT07278869
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 15
- 2026. ápr. 29. és az elsődleges befejezés (2027. szept.) között
- 3 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (3)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Arrhythmia Research Group | Jonesboro | Egyesült Államok | Toboroz |
| Cedars-Sinai Medical Center | Los Angeles | Egyesült Államok | Toboroz |
| Icahn School of Medicine at Mount Sinai | New York | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.