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

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

Georgia

Study Type

Interventional

Intervention

Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Ablation, Coherent Sine-Burst, Electroporation, CSE

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Israeli-Georgian Medical Research Clinic Helthycore LtdRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Coherent Sine-Burst Electroporation for AF

Arm Description

Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation (plus cavo-tricuspid isthmus ablation as necessary) Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation and posterior wall ablation (and cavo-tricuspid isthmus ablation as necessary)

Outcomes

Primary Outcome Measures

Serious system and procedure-related events

Incidence of system-related and procedure-related serious adverse events (SAEs).

Procedural Success

Number of patients that achieve procedural success defined as isolation of the pulmonary veins at the index or re-mapping procedure.

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.

Secondary Outcome Measures

Freedom from documented atrial fibrillation (AF)

Proportion of patients free from documented AF > or = 30 seconds of AF during follow-up.

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.

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.

Full Information

NCT ID

NCT05572047

First Posted

October 5, 2022

Last Updated

October 12, 2022

Sponsor

Arga Medtech SA

1. Study Identification

Unique Protocol Identification Number

NCT05572047

Brief Title

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

Acronym

BURST-AF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 11, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Arga Medtech SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Atrial Fibrillation, Ablation, Coherent Sine-Burst, Electroporation, CSE

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Non-randomized, multi-center

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Coherent Sine-Burst Electroporation for AF

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Arga Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Other Intervention Name(s)

CSE

Intervention Description

Use of coherent sine-burst electroporation to ablate paroxysmal and persistent AF

Primary Outcome Measure Information:

Title

Serious system and procedure-related events

Description

Incidence of system-related and procedure-related serious adverse events (SAEs).

Time Frame

Within one week (7 days) post-procedure)

Title

Procedural Success

Description

Number of patients that achieve procedural success defined as isolation of the pulmonary veins at the index or re-mapping procedure.

Time Frame

Acute and/or up to 90 days post procedure

Title

Chronic isolation of the pulmonary veins

Description

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.

Time Frame

90 to 180 days post index procedure

Secondary Outcome Measure Information:

Title

Freedom from documented atrial fibrillation (AF)

Description

Proportion of patients free from documented AF > or = 30 seconds of AF during follow-up.

Time Frame

Up to 455 days post-index procedure

Title

Freedom from documented atrial arrhythmias (AF, AT and AFL)

Description

Freedom from documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.

Time Frame

Up to 455 days post-index procedure

Title

Freedom from documented symptomatic recurrence of atrial arrhythmias

Description

Freedom from recurrence of documented atrial arrhythmias (AF, AT and AFL) > or = to 30 seconds during follow-up.

Time Frame

Up to 455 days post-index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Neale

Phone

+41(0)767792117

david@argamedtech.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giorgi Papiashvili, MD

Organizational Affiliation

Healthycore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Israeli-Georgian Medical Research Clinic Helthycore Ltd

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giorgi Papiashvili, MD

Phone

+995557520011

info@hcore.ge

First Name & Middle Initial & Last Name & Degree

Nino Kapanadze, MD

Phone

+995555593415

12. IPD Sharing Statement

Plan to Share IPD

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

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