NCT03616028Fut, nem toboroz

The CONFORMAL Early Feasibility Study

The CONFORMAL Early Feasibility Study An Evaluation of the Safety and Performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 13.

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Rövid összefoglaló (regiszter, angolul)

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Állapot (regiszter): Fut, nem toboroz
Vizsgálattípus: Beavatkozással járó
Résztvevők száma: 64 (tényleges)
Első benyújtás: 2018. júl. 30.
Kezdés: 2019. febr. 22.
Elsődleges befejezés: 2022. máj. 27.
Fő szponzor: Conformal Medical, Inc
Betegségek: Pitvarfibrilláció
NCT-szám: NCT03616028

Mit vállalsz

Vizsgálat típusa: Beavatkozással járó
Bevont résztvevők: 64
2019. febr. 22. és az elsődleges befejezés (2022. máj. 27.) között
11 helyszín, 1 országban
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Male or non-pregnant female aged ≥18 years
Documented non-valvular AF (paroxysmal, persistent, or permanent)
High risk of stroke or systemic embolism, defined as CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
The patient is recommended for oral anticoagulation therapy (OAC), but has an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulation
The patient deemed appropriate for LAA closure by the Site P.I. and a non-interventional physician using an evidenced-based decision-making tool on oral anticoagulants consistent with standard of care.
The patient is willing and able to comply with the protocol-specified medication regimen and follow-up evaluations
The patient (or legally authorized representative, (where allowed)) has been informed of the nature of the study, agrees to its provisions, 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.
Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect [ASD] or patient foramen ovale [PFO] surgical repair or implanted closure device, or obliterated or ligated left atrial appendage)
Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
Patients with a medical condition (other than atrial fibrillation) that mandates chronic oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated
Active infection with bacteremia
Documented symptomatic carotid artery disease (>50% diameter stenosis with prior ipsilateral stroke or TIA) or known asymptomatic carotid artery disease (diameter stenosis of >70%)
Recent (within 30 days pre-procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure
Recent (within 90 days pre-procedure) stroke or transient ischemic attack.
Recent (within 60 days pre-procedure) myocardial infarction
Vascular access precluding delivery of implant with catheter-based system
Severe heart failure (New York Heart Association Class III or IV)
Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant
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 <75,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <3,000 cells/mm3
Patient has a known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium, gold) 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
Patient is a prisoner
Patient is unable to undergo general anesthesia
Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 2 years
Patient has a condition which precludes adequate transesophageal echocardiographic (TEE) assessment
- Echocardiographic Exclusion Criteria
Left atrial appendage anatomy cannot accommodate the CLAAS device per manufacturer IFU
Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
Left ventricular ejection fraction (LVEF) <30%
Circumferential pericardial effusion >10 mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology
Atrial septal defect that warrants closure
High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (exclusion >15 mm or length > 15 mm) or large shunt (early [within 3 beats] or substantial passage of bubbles)
Moderate or severe mitral valve stenosis (mitral valve area <1.5 cm2)
Complex atheroma with mobile plaque of the aorta
Patient has evidence of cardiac tumor

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (11)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Texas Cardiac Arrhythmia Institute	Austin	Egyesült Államok	Ismeretlen állapot
Erlanger Health System	Chattanooga	Egyesült Államok	Ismeretlen állapot
The Christ Hospital	Cincinnati	Egyesült Államok	Ismeretlen állapot
St. Bernards Medical Center	Jonesboro	Egyesült Államok	Ismeretlen állapot
Catholic Medical Center	Manchester	Egyesült Államok	Ismeretlen állapot
Vanderbilt University Medical Center	Nashville	Egyesült Államok	Ismeretlen állapot
Columbia University Medical Center/NYPH	New York	Egyesült Államok	Ismeretlen állapot
Mount Sinai	New York	Egyesült Államok	Ismeretlen állapot
Baylor Scott & White Research Institute	Plano	Egyesült Államok	Ismeretlen állapot
Pacific Heart Institute	Santa Monica	Egyesült Államok	Ismeretlen állapot
Lankenau Heart Institute	Wynnewood	Egyesült Államok	Ismeretlen állapot

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