Stand-alone Left Atrial Appendage Occlusion for Thromboembolism Prevention

NCT05144958 | Unknown DMC FDA Device

• 1 other identifier: SALAMANDER
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long-term sequelae

  5 years

Study Arms (3)

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

Percutaneous LAAO - WATCHMAN

In this population, LAA will be occluded using an endocardial totally-percutaneous approach with the WATCHMAN device.

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.

Device: Hybrid- minimally invasive LAAO - LARIAT

Interventions

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.

Totally thoracoscopic LAAO - ATRICLIP

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.

Percutaneous LAAO - WATCHMAN

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.

Hybrid- minimally invasive LAAO - LARIAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;
• (8) Acceptable surgical candidate, including use of general anesthesia; (9) patient adherence to the study and patient Informed Consent Form has been signed

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Study Sites (1)

Department of Cardiac Surgery, Centre of Postgraduate Education

Warsaw, Mazovian, 02-507, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 36130748 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Central Study Contacts

Mariusz Kowalewski, MD, PhD

CONTACT

502269240; kowalewskimariusz@gazeta.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, M.D.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 6, 2021
• Study Start: March 1, 2019
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

PL (1)