NCT07278869招募中不适用
Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation
Append Medical Ltd.3 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年4月29日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Composite major adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Not applicable - open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Left Atrial Appendage Elimination: Append System (Device)
结局指标
主要结局
Composite major adverse events
时间窗: 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
次要结局
- Composite major adverse events(6 months)
- Procedure and Technical Success(30 days)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
2 期
A Multicentre, Open-Label, Phase 2 Safety Extension Study to Evaluate the Safety and Tolerability of R-107 in subjects with Refractory Major Depressive Disorder.Major Depressive DisorderACTRN12618001048279Douglas Pharmaceuticals Ltd.153
进行中（未招募）
1 期
An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's diseaseEUCTR2014-003855-76-SKF. Hoffmann-La Roche Ltd1,150
进行中（未招募）
1 期
Clinical Study to assess the Safety And Efficacy Of Investigational Medicinal Product Azeliragon (TTP488) In Patients With Mild Alzheimer's Disease who have previously completed a Clinical Trial with Azeliragon (TP488)MILD ALZHEIMER'S DISEASEMedDRA version: 20.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: HLT Classification code 10012268 Term: Dementia (excl Alzheimer's type) System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012294 Term: Dementia of the Alzheimer's type, with delirium System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012296 Term: Dementia of the Alzheimer's type, with depressed mood System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012293 Term: Dementia of the Alzheimer's type, uncomplicated System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: PT Classification code 10012295 Term: Dementia of the Alzheimer's type, with delusions System Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0 Level: LLT Classification code 10001896 TEUCTR2017-004065-27-GBvTv THERAPEUTICS LLC800
进行中（未招募）
1 期
This is a Phase 2, multicenter, 24-week, open-label extension (OLE) study to assess the safety and tolerability of ABT-122 in rheumatoid arthritis (RA) subjects who have completed Study M12-963.MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2014-001471-31-DEAbbVie Deutschland GmbH & Co. KG160
进行中（未招募）
1 期
Phase 2, Multicenter, Open-Label Extension (OLE) Study with ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Phase 2 Randomized Controlled Trial (RCT)MedDRA version: 18.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2014-001471-31-ROAbbVie Deutschland GmbH & Co. KG158