Atrial FibrillationSALAMANDERNCT05144958
Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention
An observational study of Atrial Fibrillation and Stroke, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Totally thoracoscopic LAAO - ATRICLIP, Percutaneous LAAO - WATCHMAN and Hybrid- minimally invasive LAAO - LARIAT
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2019to 1 Mar 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- patients aged ≥18 years;
- ECG/Holter diagnosis of AF;
- Previous stroke or systemic thromboembolic complications;
- High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2;
- HASBLED score of > 2;
- Contraindications to oral anticoagulation or Complications of oral anticoagulation;
- Acceptable surgical candidate, including use of general anesthesia; (9) patient adherence to the study and patient Informed Consent Form has been signed
Who cannot join
- No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or implantable loop recorder) or only atrial flutter recorded,
- Significant valve disease or coronary multivessel artery lesions requiring operation;
- Stroke/cerebrovascular accident (CVA) within previous 30 days;
- Critical preoperative state;
- participation in a clinical trial
- patient refusal
Show all 15Show fewer
- Registry imposes intraoperative exclusion criteria to otherwise enrolled patients:
- Presence of thrombus in the LA or LAA
- LAA tissue with significant adhesions (as evaluated by the surgeon) making AtriClip® placement overly risky.
- Previous cardiac operations (e.g., CABG, heart transplant, valvular replacement) making LARIAT placement overly risky.
- Patients with a previous atrial septal defect with surgical or transcatheter closure making Watchman placement overly risky.
- NYHA IV;
- Right-sided heart failure;
- Symptomatic carotid artery disease;
- active systemic infection.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, Centre of Postgraduate Education
Warsaw, Mazovian, 02-507
Mariusz Kowalewski, MD, PhD, 664365477 ext. 0048, kowalewskimariusz@gazeta.pl
About this study
Official title: Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Totally thoracoscopic LAAO - ATRICLIP, Percutaneous LAAO - WATCHMAN, Hybrid- minimally invasive LAAO - LARIAT
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Totally thoracoscopic LAAO - ATRICLIPDevice
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.
Percutaneous LAAO - WATCHMANDevice
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.
Hybrid- minimally invasive LAAO - LARIATDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Totally thoracoscopic LAAO - ATRICLIP | In this group, LAA will be sealed using the epicardial thoracoscopic approach with the ATRICLIP device. Receives: Device: Totally thoracoscopic LAAO - ATRICLIP | |
| Percutaneous LAAO - WATCHMAN | In this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device. Receives: Device: Percutaneous LAAO - WATCHMAN | |
| Hybrid- minimally invasive LAAO - LARIAT | In these patients, LAA will be closed using a hybrid, combined endo- and epicardial approach using the LARIAT system. Receives: Device: Hybrid- minimally invasive LAAO - LARIAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Mar 2019
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariusz Kowalewski, Nicolaus Copernicus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144958
- Sponsor's protocol ID
- SALAMANDER
- Acronym
- SALAMANDER
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 42132197Kowalewski 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.
PubMed 36130748
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand-Alone Left Atrial Appendage Occlusion for throMboembolism Prevention in Nonvalvular Atrial fibrillatioN DiseasE Registry (SALAMANDER)
- ClinicalTrials.gov ID
- NCT05144958
- Acronym / sponsor ID
- SALAMANDER / SALAMANDER
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Totally thoracoscopic LAAO - ATRICLIP | – | Device: Totally thoracoscopic LAAO - ATRICLIPIn this group, LAA will be sealed using the epicardial thoracoscopic approach with the ATRICLIP device. |
| Percutaneous LAAO - WATCHMAN | – | Device: Percutaneous LAAO - WATCHMANIn this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device. |
| Hybrid- minimally invasive LAAO - LARIAT | – | Device: Hybrid- minimally invasive LAAO - LARIATIn these patients, LAA will be closed using a hybrid, combined endo- and epicardial approach using the LARIAT system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- patients aged ≥18 years;
- ECG/Holter diagnosis of AF;
- Previous stroke or systemic thromboembolic complications;
- High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2;
- HASBLED score of > 2;
Key exclusion criteria (15 listed)
- No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or implantable loop recorder) or only atrial flutter recorded,
- Significant valve disease or coronary multivessel artery lesions requiring operation;
- Stroke/cerebrovascular accident (CVA) within previous 30 days;
- Critical preoperative state;
- participation in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totally thoracoscopic LAAO - ATRICLIPThe 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. | Device | Totally thoracoscopic LAAO - ATRICLIP |
| Percutaneous LAAO - WATCHMANUsing 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. | Device | Percutaneous LAAO - WATCHMAN |
| Hybrid- minimally invasive LAAO - LARIATLARIAT 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. | Device | Hybrid- minimally invasive LAAO - LARIAT |
Primary outcome
Safety and efficacy
Time frame: 30 days
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
1 secondary outcome
Long-term sequelae
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Derived from this study: PubMed 42132197Wanha 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.
- Derived from this study: PubMed 36130748Kowalewski 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Nicolaus Copernicus University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariusz Kowalewski, MD, PhD (502269240 ext. 0048, kowalewskimariusz@gazeta.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144958, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.