Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— BURST-AF  

Official title:

Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572047
• Other study ID #: CIP CSR 01-2022
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2022
• Source: Arga Medtech SA
• Contact: David Neale
• Phone: +41(0)767792117
• Email: david[@]argamedtech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.

Description:

A prospective, single-arm, multi-center, multi-national, non-randomized study designed to provide clinical data to support the use of the Arga Medtech System in the ablation of atrial fibrillation.

Patients with paroxysmal AF will be treated using the Arga Medtech System to achieve pulmonary vein isolation (PVI) (and cavo-tricuspid isthmus (CTI) ablation as appropriate if history of CTI flutter or inducible flutter during procedure)

Patients with persistent AF will be treated using the Arga Medtech System to achieve PVI and posterior wall (PW) ablation (CTI ablation as above).

Patients will be remapped at 90 days post the index procedure to confirm absence of PV reconnection and durability of any additional lesion sets performed. Re-ablation is permitted during the remapping procedure if indicated. Re-ablation resets the 90-day blanking period.

Additional follow-ups will be conducted at 7 days, 30 days, 180 days and 360 days post the index or re-ablation procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Scheduled for ablation of paroxysmal or persistent AF

• 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

• Failed at least one antiarrhythmic drug (AAD) (Class I to IV) as evidenced by recurrent symptomatic AF or intolerable or contraindicated to the AAD

Exclusion Criteria:

• Contraindication to AF ablation, TEE or anticoagulation

• Duration of continuous AF lasting longer than 12 months

• History of previous LA ablation or surgical treatment of AF/AT/AFL

• AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiac cause

• Structural heart disease described as:

• LVEF <30% based on TTE within 6 months of procedure

• Left atrial size > 50mm based on TTE within 6 months of procedure (parasternal view)

• An implanted pacemaker or ICD

• Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG)

• Previous cardiac valvular surgical or percutaneous procedure or prosthetic valve

• Interatrial baffle, closure device, patch, ASD or PFO

• Presence of a left atrial appendage occlusion device

• CABG or PTCA procedure within the last 6 months

• Unstable angina or ongoing myocardial ischemia

• Myocardial infarction within the previous 6 months

• Hypertrophic cardiomyopathy defined as left ventricular septal wall thickness > 1.5cm

• History of blood clotting or bleeding disease

• Prior history within the previous 6 months of documented cerebral infarction, TIA or system embolism

• Pregnant or lactating (current or anticipated within study follow-up)

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF

Locations

Country	Name	City	State
Georgia	Israeli-Georgian Medical Research Clinic Helthycore Ltd	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Arga Medtech SA

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious system and procedure-related events	Incidence of system-related and procedure-related serious adverse events (SAEs).	Within one week (7 days) post-procedure)
Primary	Procedural Success	Number of patients that achieve procedural success defined as isolation of the pulmonary veins at the index or re-mapping procedure.	Acute and/or up to 90 days post procedure
Primary	Chronic isolation of the pulmonary veins	Rate of patients and targeted pulmonary veins with documented electrical isolation of the pulmonary veins, assessed by entrance and exit block during a mapping procedure ~90-days post procedure.	90 to 180 days post index procedure
Secondary	Freedom from documented atrial fibrillation (AF)	Proportion of patients free from documented AF > or = 30 seconds of AF during follow-up.	Up to 455 days post-index procedure
Secondary	Freedom from documented atrial arrhythmias (AF, AT and AFL)	Freedom from documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.	Up to 455 days post-index procedure
Secondary	Freedom from documented symptomatic recurrence of atrial arrhythmias	Freedom from recurrence of documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.	Up to 455 days post-index procedure