Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention (SALAMANDER)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Device: Totally thoracoscopic LAAO - ATRICLIP; Device: Percutaneous LAAO - WATCHMAN; Device: Hybrid- minimally invasive LAAO - LARIAT

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Mariusz Kowalewski, MD, PhD; Phone Number: 0048 502269240; Email: kowalewskimariusz@gazeta.pl

Study Locations

• Poland
  • Mazovian
    • Warsaw, Mazovian, Poland, 02-507
      • Recruiting
      • Department of Cardiac Surgery, Centre of Postgraduate Education
      • Contact: Mariusz Kowalewski, MD, PhD; Phone Number: 0048 664365477; Email: kowalewskimariusz@gazeta.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. patients aged ≥18 years;
2. ECG/Holter diagnosis of AF;
3. Previous stroke or systemic thromboembolic complications;
4. High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2;
5. HASBLED score of > 2;
6. Contraindications to oral anticoagulation or Complications of oral anticoagulation;

(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:

1. No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or implantable loop recorder) or only atrial flutter recorded,
2. Significant valve disease or coronary multivessel artery lesions requiring operation;
3. Stroke/cerebrovascular accident (CVA) within previous 30 days;
4. Critical preoperative state;
5. participation in a clinical trial
6. patient refusal

Registry imposes intraoperative exclusion criteria to otherwise enrolled patients:

1. Presence of thrombus in the LA or LAA
2. LAA tissue with significant adhesions (as evaluated by the surgeon) making AtriClip® placement overly risky.
3. Previous cardiac operations (e.g., CABG, heart transplant, valvular replacement) making LARIAT placement overly risky.
4. Patients with a previous atrial septal defect with surgical or transcatheter closure making Watchman placement overly risky.
5. NYHA IV;
6. Right-sided heart failure;
7. Symptomatic carotid artery disease;
8. active systemic infection.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Totally thoracoscopic LAAO - ATRICLIP; In this group, LAA will be sealed using the epicardial thoracoscopic approach with the ATRICLIP device.	Device: Totally thoracoscopic LAAO - ATRICLIP; 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 - WATCHMAN; In this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device.	Device: Percutaneous LAAO - WATCHMAN; 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 - LARIAT; In these patients, LAA will be closed using a hybrid, combined endo- and epicardial approach using the LARIAT system.	Device: Hybrid- minimally invasive LAAO - LARIAT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Atrial Fibrillation; Thromboembolism
• Other Study ID Numbers: SALAMANDER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes