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This prospective nationwide registry aims to assess the durability of left atrial appendage occlusion when performed via totally thoracoscopic, percutaneous and hybrid- minimally invasive approaches and collect information on possible adverse events.
Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in Nonvalvular Atrial Fibrillation DiseasE Registry (SALAMANDER) will commence in 37 heart surgery centers across Poland and has no limit of patient recruitment. Included in the registry will be all >18 y.o. patients with AF and high risk of thromboembolic and bleeding complications defined by CHA2DS2-VASc Score > 2 and HASBLED score of > 2 referred to stroke prevention who do not require an open chest surgery for other reasons. The primary outcome will be the number of perioperative (in-hospital/30-days) complications associated with LAA closure device placement and intraoperative success of exclusion of LAA as assessed by transesophageal echocardiography. Secondary outcomes will be major adverse cardiac and cerebrovascular events (MACCE, combined endpoint of death, acute heart failure, myocardial infarction and stroke); pulmonary complications and any complications connected with surgical intervention. AF-related risks, including stroke/systemic thromboembolism and bleeding outcomes, will be assessed. Medical history, risk factors, demographic information and management will be collected at baseline, and clinical events during 1 -year follow-up will be recorded. Follow-up will be conducted for at least 1 year and then annually thereafter till year 5th post-op.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Totally thoracoscopic LAAO - ATRICLIP | In this group, LAA will be sealed using the epicardial thoracoscopic approach with the ATRICLIP device. |
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| Percutaneous LAAO - WATCHMAN | In this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device. |
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| Hybrid- minimally invasive LAAO - LARIAT | In these patients, LAA will be closed using a hybrid, combined endo- and epicardial approach using the LARIAT system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Totally thoracoscopic LAAO - ATRICLIP | Device | The device for surgical totally thoracoscopic left atrial appendage occlusion AtriClip® Gillinov-Cosgrove™ (AtriClip, AtriCure, Dayton, OH, USA) consists of an automatically closing clip placed in a deployment loop on a disposable holder with the head articulation of 60 degrees side-to-side and up/down. The several novel features of the system in comparison to previous ones, such as its length, maneuverability and releasing system, enable it to be used in a totally thoracoscopic fashion. The AtriClip® PRO has parallel titanium crossbars that equalize the force over the tissue trabeculations of the LAA during deployment, ensuring a sealed line at the base of the LAA orifice, as confirmed in preclinical and clinical studies. The clip can be opened and closed repeatedly before final deployment when only the correct placement is confirmed in TEE. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy | The number of peri-operative (in-hospital/30-days) complications associated with LAA closure device placement and intraoperative success of exclusion of LAA as assessed by transesophageal echocardiography | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term sequelae | Major adverse cardiac and cerebrovascular events (MACCE, combined endpoint of death, acute heart failure, myocardial infarction and stroke); pulmonary complications and any complications connected with surgical intervention. | 5 years |
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Inclusion Criteria:
(8) Acceptable surgical candidate, including use of general anesthesia; (9) patient adherence to the study and patient Informed Consent Form has been signed
Exclusion Criteria:
Registry imposes intraoperative exclusion criteria to otherwise enrolled patients:
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Adult patients with non-valvular AF and high risk of thromboembolic and bleeding complications defined by CHA2DS2-VASc Score > 2 and HAS-BLED score of > 2 referred to stroke prevention who do not require an open chest surgery for other reasons.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariusz Kowalewski, MD, PhD | Contact | 502269240 | 0048 | kowalewskimariusz@gazeta.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac Surgery, Centre of Postgraduate Education | Recruiting | Warsaw | Mazovian | 02-507 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42132197 | Derived | Wanha W, Kuzma L, Kowalewski M, Iwanczyk S, Grygier J, Jeske J, Frazzetto M, Litwinowicz R, Burysz M, Gaszewska-Zurek E, Sanfilippo C, Bochenek T, Lelek M, Wita K, Huczek Z, Kaplon-Cieslicka A, Mazurek T, Scislo P, Sacha J, Struniawski K, Tomasiewicz B, Mezque F, Kuliczkowski W, Bartus K, Dobrzycki S, Swieczkowski M, Kurasz A, Kralisz P, Miskowiec D, Kasprzak JD, Chamera M, Mielczarek M, Drewla P, Galaska R, Ugo F, Franzino M, Cortese B, Gurgoglione FL, Vignali L, Benatti G, Barocelli F, Wacinski P, Niezgoda P, Sukiennik A, Kubica J, Iannacone M, Kowalska K, Lewicki L, Grasso C, Capodanno D, D'Ascenzo F, de Filippo O, Bruno F, Gocol R, Kalarus Z, Suwalski P, Grygier M, Smolka G, Lip GYH, Wojakowski W. Primary Results of the SALAMANDER Registry: A Multicenter Observational Cohort Study. J Am Heart Assoc. 2026 May 19;15(10):e046625. doi: 10.1161/JAHA.125.046625. Epub 2026 May 14. | |
| 36130748 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Percutaneous LAAO - WATCHMAN | Device | Using a modified Seldinger technique a vessel dilator and a guidewire are inserted into the femoral vein. Under trans-esophageal echocardiography and fluoroscopy guidance, an interatrial septum is punctured using typical trans-septal access. The pigtail catheter is placed in the distal portion of the left atrial appendage and then the access sheath is inserted. After choosing the appropriate Watchman size the device is deployed and seals the left atrial appendage. |
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| Hybrid- minimally invasive LAAO - LARIAT | Device | LARIAT system consists of: A) endocardial magnet-tipped guidewire. It is placed inside the left atrial appendage through the introduction of a catheter into the femoral vein; B) epicardial magnet-tipped guidewire. It is placed on the outside of the left atrium through the atrial appendage puncture of the pericardium. Each wire has a magnet of opposite polarity enabling end-to-end alignment; C) A compliant occlusion balloon catheter to identify the LAA and allow for a very precise and effective seal of the left atrial appendage; D) The LARIAT suture delivery device. It is introduced by an earlier puncture of the pericardium in the vicinity of the left atrial appendage and guided over magnet wire onto the base of the LAAO. With the LARIAT suture delivery device, the lumen of the left atrial appendage is closed from outside the heart, resulting in the elimination of the thrombus source. |
|
| Derived |
| Kowalewski M, Wanha W, Litwinowicz R, Kolodziejczak M, Pasierski M, Januszek R, Kuzma L, Grygier M, Lesiak M, Kaplon-Cieslicka A, Reczuch K, Gil R, Pawlowski T, Bartus K, Dobrzycki S, Lorusso R, Bartus S, Deja MA, Smolka G, Wojakowski W, Suwalski P. Stand-Alone Left Atrial appendage occlusion for throMboembolism prevention in nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER): protocol for a prospective observational nationwide study. BMJ Open. 2022 Sep 21;12(9):e063990. doi: 10.1136/bmjopen-2022-063990. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |