Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000778482p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2025
Date registered
24/07/2025
Date last updated
24/07/2025
Date data sharing statement initially provided
24/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
First-In-Human Study to evaluate the safety and feasibility of EnCompass-S2 ARFA PFA (Advanced Radiofrequency Ablation Pulsed Field Ablation) Dual Energy Clamp in patients undergoing cardiac ablation during a concomitant cardiac surgical procedure. (EnCompass-S2 FIH)
Scientific title
First-In-Human Study to evaluate the safety and feasibility of EnCompass-S2 ARFA PFA Dual Energy Clamp in patients undergoing cardiac ablation during a concomitant cardiac surgical procedure. (EnCompass-S2 FIH)
Secondary ID [1] 314857 0
CP-2025-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 338131 0
Condition category
Condition code
Cardiovascular 334417 334417 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331459 0
Treatment: Devices
Comparator / control treatment
No controlled group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342112 0
Safety serious adverse events related to the study device
Timepoint [1] 342112 0
through 30-days post procedure
Secondary outcome [1] 449591 0
Acute isolation of the BoxX lesion.
Timepoint [1] 449591 0
Periprocedural
Secondary outcome [2] 449592 0
Procedural times, this will be assessed as a composite outcome.
Timepoint [2] 449592 0
Peri-procedural

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
No formal statistical analysis will be performed on these data given the limited sample size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2025
Actual
Date of last participant enrolment
Anticipated
30/01/2026
Actual
Date of last data collection
Anticipated
30/01/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28193 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 44405 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 319415 0
Commercial sector/Industry
Name [1] 319415 0
AtriCure, Inc
Country [1] 319415 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ClinTrail Pty
Address
Country
Australia
Secondary sponsor category [1] 321901 0
Commercial sector/Industry
Name [1] 321901 0
AtriCure, Inc
Address [1] 321901 0
Country [1] 321901 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317986 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317986 0
Ethics committee country [1] 317986 0
Australia
Date submitted for ethics approval [1] 317986 0
09/07/2025
Approval date [1] 317986 0
Ethics approval number [1] 317986 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142786 0
Prof Jayme Bennetts
Address 142786 0
Victorian Heart Hospital, 631 Blackburn Rd, Clayton VIC 3168
Country 142786 0
Australia
Phone 142786 0
+61 3 75111555
Fax 142786 0
Email 142786 0
[email protected]
Contact person for public queries
Name 142787 0
Jess Lampert
Address 142787 0
AtriCure, Inc. 7555 Innovation Way Mason, Ohio 45040
Country 142787 0
United States of America
Phone 142787 0
+1 513 755 4100
Fax 142787 0
Email 142787 0
[email protected]
Contact person for scientific queries
Name 142788 0
Jess Lampert
Address 142788 0
AtriCure, Inc. 7555 Innovation Way Mason, Ohio 45040
Country 142788 0
United States of America
Phone 142788 0
+1 513 755 4100
Fax 142788 0
Email 142788 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.