First in Human Study with the EnCompass-S Clamp in patients undergoing Atrial Fibrillation ablation during a simultaneous cardiac surgical procedure.

First in Human Study to evaluate the performance of Encompass-S Clamp in patients undergoing AF ablation during a concomitant cardiac surgical procedure.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001350516

Enrollment

Registered

2024-11-08

Start date

2025-03-17

Completion date

2025-09-29

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 STS and HRS guidelines. The AtriCure Isolator Synergy EnCompass-S Ablation System will be used to treat AF as part of planned cardiac surgery. The objective of Encompass-S First in Human study is to evaluate the performance of Encompass-S in patients undergoing AF ablation concomitant to cardiac surgery.

Interventions

Ablation of atrial fibriliation in patients undergoing the procedure as an concommittant cardiac surgical procedure using the AtriCure Isolator Synergy EnCompass-S Ablation System inclusive of generators, clamp and assessories as below: AtriCure Isolator Synergy EnCompass-S Ablation System: • Generators: AtriCure RF generator (ASU3) AtriCure RF generator (ASB3) • Clamp: Isolator Synergy EnCompass-S Clamp (OLH-S) • Accessories: Clamp Guide (GPM100) Handpiece Adapter Footswitch Adapter Footswitch 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 Ablation System will be perfomed by qualified Cardithoracic 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 occurances 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 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 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 No maximum

Healthy volunteers

Inclusion criteria

• 18 years of age or older • Scheduled for ablation of AF during Coronary Artery Bypass Graft (CABG)or Aortic Valve Replacement (AVR) surgery or a combination • Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the duration of the study • Willing and able to give informed consent • Refractory or intolerant to at least one Class I/III antiarrhythmic agent

Exclusion criteria

• Contraindication to AF ablation, TEE, or anticoagulation • Duration of continuous AF lasting longer than 12 months • History of previous Left Atrium (LA) ablation or surgical treatment of AF/AT/AFL • AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause • Need for emergent cardiac surgery • Structural heart disease described as: • LVEF <30% based on TTE within 6 months of procedure • Left atrial size > 65mm based on TTE within 6 months of procedure (parasternal view) • Class IV New York Heart Association (NYHA) heart failure symptoms • Previous cardiac surgery • Prior LAA occlusion, exclusion, or removal (surgical or percutaneous) • PCI procedure within the last 3 months • Documented history of pulmonary hypertension (Class III or IV with a mean pulmonary artery pressure >40 mm Hg) • Carotid artery stenosis greater than 80% • Unstable angina or ongoing myocardial ischemia • Myocardial infarction within the previous 3 months • History of blood clotting or bleeding disease • Renal failure requiring dialysis or hepatic failure • Prior history within the previous 6 months of documented cerebral infarction, TIA or system embolism • Pregnant or lactating • Nickel allergy • Evidence of active infection or endocarditis • 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). • Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcomes measurement for this study • 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.

Outcome results