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Trial registered on ANZCTR


Registration number
ACTRN12624001350516p
Ethics application status
Submitted, not yet approved
Date submitted
7/10/2024
Date registered
8/11/2024
Date last updated
8/11/2024
Date data sharing statement initially provided
8/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
First in Human Study with the EnCompass-S Clamp in patients undergoing Atrial Fibrillation ablation during a simultaneous cardiac surgical procedure.
Scientific title
First in Human Study to evaluate the performance of Encompass-S Clamp in patients undergoing AF ablation during a concomitant cardiac surgical procedure.
Secondary ID [1] 312976 0
CP-2024-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 335157 0
Condition category
Condition code
Cardiovascular 331650 331650 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 329514 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339576 0
Safety
Timepoint [1] 339576 0
Through to 30 days post procedure at the following timepoints, procedure day, pre-discharge (discharge day or at 7 days post procedure, whichever is sooner), 30 days post procedure +- 7 days, unscheduled assessments as required by the Principal Investigator,
Secondary outcome [1] 440486 0
Procedural times
Timepoint [1] 440486 0
During the surgical procedure using the AtriCure Isolator Synergy EnCompass-S Ablation System.
Secondary outcome [2] 441174 0
Recording of intraoperative times including cross clamp time
Timepoint [2] 441174 0
During the surgical procedure using the AtriCure Isolator Synergy EnCompass-S Ablation System.
Secondary outcome [3] 441175 0
Recording of intraoperative times including ablation procedure time
Timepoint [3] 441175 0
During the surgical procedure using the AtriCure Isolator Synergy EnCompass-S Ablation System.

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

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
Safety/efficacy
Statistical methods / analysis
No formal statistical analysis will be performed on these data given the limited sample size. Rather, the primary endpoint is a quantification of the occurrence of the primary safety events through 30 days related to the investigational study device.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
1/05/2025
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27199 0
Victorian Heart Hospital - Clayton
Recruitment postcode(s) [1] 43281 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 317416 0
Commercial sector/Industry
Name [1] 317416 0
AtriCure, Inc
Country [1] 317416 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
ClinTrial Pty
Address
Country
Australia
Secondary sponsor category [1] 319699 0
Commercial sector/Industry
Name [1] 319699 0
AtriCure, Inc
Address [1] 319699 0
Country [1] 319699 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316287 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316287 0
Ethics committee country [1] 316287 0
Australia
Date submitted for ethics approval [1] 316287 0
06/11/2024
Approval date [1] 316287 0
Ethics approval number [1] 316287 0

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

Contacts
Principal investigator
Name 136902 0
Prof Jayme Bennetts
Address 136902 0
Victorian Heart Hospital, 631 Blackburn Rd, Clayton VIC 3168
Country 136902 0
Australia
Phone 136902 0
+61 410 653 200
Fax 136902 0
Email 136902 0
jayme.bennetts@monashhealth.org
Contact person for public queries
Name 136903 0
Jess Lampert
Address 136903 0
AtriCure, Inc. 7555 Innovation Way Mason, Ohio 45040
Country 136903 0
United States of America
Phone 136903 0
+1 513 755 4100
Fax 136903 0
Email 136903 0
Jlampert@AtriCure.com
Contact person for scientific queries
Name 136904 0
Jess Lampert
Address 136904 0
AtriCure, Inc. 7555 Innovation Way Mason, Ohio 45040
Country 136904 0
United States of America
Phone 136904 0
+1 513 755 4100
Fax 136904 0
Email 136904 0
Jlampert@AtriCure.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.