Clinical trial NCT05572047: Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients with Atrial Fibrillation
Official title: Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients with Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Ablation
Coherent Sine-Burst
Electroporation
CSE
Lead sponsor: Arga Medtech SA
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized, multi-center
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Serious system and procedure-related events
timeFrame: Within one week (7 days) post-procedure)
measure: Procedural Success
timeFrame: Acute and/or up to 90 days post procedure
measure: Chronic isolation of the pulmonary veins
timeFrame: 90 to 180 days post index procedure
Secondary outcomes:
measure: Freedom from documented atrial fibrillation (AF)
timeFrame: Up to 455 days post-index procedure
measure: Freedom from documented atrial arrhythmias (AF, AT and AFL)
timeFrame: Up to 455 days post-index procedure
measure: Freedom from documented symptomatic recurrence of atrial arrhythmias
timeFrame: Up to 455 days post-index procedure
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital of Split
city: Zagreb
country: Croatia
facility: KBC Zagreb
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helthycore Ltd
Study officials:
affiliation: University Hospital of Split
name: Ante Anic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Israeli-Georgian Medical Research Clinic Helsicore
name: Giorgi Papiashvili
role: PRINCIPAL_INVESTIGATOR
References: