None listed
Conditions
Brief summary
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia worldwide. Surgical ablation for the treatment of AF during concomitant cardiac surgery is a class I recommendation per Society of Thoracic Surgeons (STS) and Heart Rhythm Society (HRS) guidelines. The AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System will be used to treat AF as part of planned cardiac surgery. The objective of this study is to evaluate the safety and feasibility of the Isolator Synergy EnCompass-S2 AFRA PFA Dual Energy System in participants with atrial fibrillation (AF) undergoing cardiac ablation concomitant to cardiac surgery.
Interventions
The Encompass-S2 device will be used to complete concomitant surgical ablations of atrial fibrillation within cardiac surgery.
Ablation of atrial fibrillation in patients undergoing the procedure as an concomitant cardiac surgical procedure using the AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System: inclusive of generators, clamp and accessories as below:
AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System:
• Generators:
o AtriCure RF generator (
The Encompass-S2 device will be used to complete concomitant surgical ablations of atrial fibrillation within cardiac surgery. Ablation of atrial fibrillation in patients undergoing the procedure as an concomitant cardiac surgical procedure using the AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System: inclusive of generators, clamp and accessories as below: AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System: • Generators: o AtriCure RF generator (ASU2) o AtriCure RF generator (ASB3) o PFA Generator (PFAS) • Clamp: o Isolator Synergy EnCompass-S2 ARFA PFA Dual Energy Clamp (OLH-S2) • Accessories: o Clamp Guide (GPM100) o Handpiece Adapter o Footswitch Adapter Generators are capital equipment and will be used in all procedures. Clamp and accessories are disposable and will be discarded after each case. The AF ablation procedure using the AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System will be performed by qualified Cardiothoracic Surgeons who frequently complete these procedures as a clinical standard of care. The AtriCure Isolator Synergy EnCompass-S Ablation System will be used in one planned surgical procedure per patient, the number intra-procedural of energy delivery occurrences will vary dependent on the number of lesions required to clinically treat the patient. The planned cardiac surgical procedures using the AtriCure Isolator Synergy EnCompass-S ARFA PFA Dual Energy Ablation System will be completed in tertiary public cardiac hospital. Investigational part of the procedure is approximately 20 minutes. Total procedure time is approximately 3-4 hours (concomitant + surgical ablation). Study data will be gathered from procedural records and additional specifications from the sponsor. The sponsor will have case support representatives in all procedures. Data will be collected for safety monitoring up until 12 months, endpoint data is only up to 30 days.
Sponsors
ClinTrail Pty
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Scheduled for ablation of Atrial fibrillation (AF) during a non-emergent on-pump open sternotomy procedure for Coronary Artery Bypass Graft (CABG), Aortic Valve Replacement or Repair (AVR), Mitral Valve Replacement or Repair (MVR), or a combination. 2. Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the duration of the study 3. Willing and able to give informed consent 4. Participants between 18 - 85 years of age
Exclusion criteria
1. Contraindication to Atrial Fibrillation (AF) ablation, Transoesophageal Echocardiography (TEE) or anticoagulation 2. Duration of continuous AF lasting > 12 months 3. History of previous Left Atrial (LA) ablation or surgical treatment of AF / Atrial Tachycardia (AT) / Atrial Flutter (AFL) 4. AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause 5. Need for emergent cardiac surgery 6. Structural heart disease described as o Left ventricular ejection fraction (LVEF) 60mm based on TTE within 6 months of procedure (parasternal view) OR Left Atrial Volume Index (LAVI) of >120 mL/m2 7. Class IV New York Heart Association (NYHA) heart failure symptoms 8. Previous cardiac surgery 9. Prior Left Atrial Appendage (LAA) occlusion, exclusion, or removal (surgical or percutaneous) 10. Percutaneous Coronary Intervention (PCI) procedure within 3 months 11. Documented history of pulmonary hypertension (Class III or IV with a mean pulmonary artery pressure >40 mm Hg) 12. Carotid artery stenosis >80% 13. Unstable angina or ongoing myocardial ischemia 14. Myocardial infarction within 3 months 15. History of blood clotting or bleeding disease 16. Renal failure requiring dialysis or hepatic failure 17. Prior history of documented cerebral infarction, stroke, transient ischaemic attack (TIA) or systemic arterial embolism 18. Pregnant 19. Current enrolment in any other study protocol where testing or results from that study may interfere with the procedure or outcomes measurement for this study 20. Nickel allergy 21. Any other condition, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol 22. Evidence of active systemic infection or endocarditis 23. Patient has presence of thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative TEE) 24. Presence of hypertrophic obstructive cardiomyopathy.
Outcome results
None listed