Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation

NCT06784466 | Recruiting DMC FDA Device

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 360
• Locations: 6 countries
• Sites: 27

Brief Summary

To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.

Conditions

Atrial Fibrillation (AF); Persistant Atrial Fibrillation; Paroxysmal AF

Keywords

atrial fibrillation; ablation; coherent sine-burst; electroporation; pulsed field ablation

Outcome Measures

Primary Outcomes (2)

• Safety: Number of Participants With at Least One Primary Safety Event.

  Primary safety events are: Within 7 days of the index procedure: * Complete heart block * Coronary spasm * Myocardial infarction * Peripheral or organ thromboembolism * Stroke * Transient ischemic attack * Unresolved phrenic nerve palsy * Vascular access complications * Pericarditis Within 30 days of the index procedure: * Acute renal failure * Cardiac tamponade / perforation * Cardiovascular or pulmonary Pulsed Field Ablation (PFA)-related hospitalization * Death * Gastroparesis * Major bleeding Within180 days of the index procedure: * Pulmonary vein stenosis (≥70% diameter reduction) * Esophageal perforating complications

  Up to 180 days

• Effectiveness: Number of Participants With Treatment Success.

  Treatment success is defined as freedom from treatment failure. 1. Acute Procedural Success and 2. Chronic Success: * Documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) on a 12-lead electrocardiogram (ECG), event monitor, or Holter monitor after the 90-day Blanking Period * Re-ablation in the left atrium for AF, AFL, or AT * Any electrical cardioversion for AF, AFL, or AT * Any Class I or III antiarrhythmic (AAD) dose increase from the historic maximum ineffective dose prior to the Index Procedure or initiation of any new Class I or III AAD.

  Up to 12 months

Secondary Outcomes (2)

• Quality of Life - Change in EQ-5D-3L Score

  Baseline to 12 months post-ablation

• Quality of Life - Change in The AF Effect on Quality-of-Life questionnaire (AFEQT) Score

  Baseline to 12 months post-ablation

Study Arms (2)

Paroxysmal AF

EXPERIMENTAL

Patients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.

Device: Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Persistent AF

EXPERIMENTAL

Patients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.

Device: Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Interventions

Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System DEVICE

Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System

Paroxysmal AF; Persistent AF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18 and 80 years, or older than 18 if required by local law.
• Diagnosis of drug refractory, recurrent, paroxysmal or persistent AF:
• a. Symptomatic paroxysmal AF that is less than 7 days in continuous duration, documented by the following: i. Physician documentation of symptomatic recurrent PAF (2 or more episodes) within 6 months prior to enrollment AND ii. At least 1 documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment.
• b. Symptomatic persistent AF that is sustained beyond 7 days and less than 1 year (≥ 7 and ≤ 365 days), documented by the following: i. Physician documentation of at least 1 symptomatic persistent AF episode within 6 months prior to enrollment.
• ii. Either a 24-hour continuous ECG recording documenting continuous AF OR 2 ECGs from any regulatory cleared rhythm monitoring device showing continuous AF taken at least 7 days apart, within 6 months prior to enrollment.
• Effectiveness failure of, intolerance to, or a specific contraindication to at least one Class I or III anti-arrhythmic drug.
• Willing and able to give informed consent.
• Willingness, ability, and commitment to participate in baseline, follow-up, and rhythm monitoring evaluations for the full length of the study.
• Life expectancy \>1 year.

You may not qualify if:

• In the opinion of the Investigator, any known contraindication to an AF ablation (including present left atrial \[LA\] thrombus), trans-esophageal echocardiogram (TEE) or computed tomography (CT) scan, or anticoagulation.
• Any duration of continuous AF lasting longer than 12 months.
• History of any previous left atrial ablation or surgical procedure, including prior left atrial appendage closure.
• AF secondary to electrolyte imbalance, thyroid disease, alcohol, or any other reversible or non-cardiac cause.
• Left ventricular ejection fraction (LVEF) \< 35% within 6 months of enrollment (e.g. transthoracic echocardiogram (TTE), multiple-gated acquisition (MUGA), magnetic resonance imaging (MRI), nuclear stress test).
• New York Heart Association (NYHA) Class III or IV.
• Left atrial diameter \> 5.0 cm (anteroposterior) within 6 months of enrollment (MRI, CT, TTE, TEE, or physician's note) or non-indexed volume \>100mL if left atrial diameter is not available.
• Current or anticipated implant of a permanent pacemaker, implantable cardioverter or resynchronization device, interatrial baffle, foramen ovale occluder, LA appendage closure, or active implantable/insertable cardiac loop recorder/monitor at the time of the ablation procedure.
• Body mass index (BMI) \>40.
• Patients who have not been on anticoagulation therapy for at least 3 weeks prior to the Index Procedure.
• Previous cardiac surgery, myocardial infarction, percutaneous coronary intervention or angioplasty (PCI/PTCA) or coronary artery stenting within 3 months prior to enrollment.
• Symptomatic valvular disease, history of cardiac valve surgery, or prosthetic mitral and tricuspid valve(s).
• Presence of pulmonary vein abnormalities of stenosis or stenting.
• Primary pulmonary hypertension.
• Uncontrolled or untreated hypertension (two measurements of \>180mmHg systolic or \>110 mmHg diastolic at baseline).

Sponsors & Collaborators

• Arga Medtech SA: lead

Study Sites (27)

Grandview

Birmingham, Alabama, 35243, United States

RECRUITING

Banner University Med Ctr

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

RECRUITING

UCSD

San Diego, California, 92037-7411, United States

RECRUITING

Ascension / St. Vincent's Jacksonville

Jacksonville, Florida, 32204, United States

RECRUITING

Advent Health

Orlando, Florida, 32803, United States

RECRUITING

Emory

Atlanta, Georgia, 30322, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Prairie Education & Research Cooperative

Springfield, Illinois, 62769, United States

RECRUITING

Kansas City Heart Rhythm Institute (KCHRI)

Overland Park, Kansas, 66212, United States

RECRUITING

Baptist Health Lexington

Lexington, Kentucky, 30322, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

TriHealth Cincinnati

Cincinnati, Ohio, 45202, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio Health Research and Innovation Institute

Columbus, Ohio, 43214, United States

RECRUITING

Trident Medical Center

Charleston, South Carolina, 29406, United States

RECRUITING

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

RECRUITING

Methodist

San Antonio, Texas, 78229, United States

RECRUITING

AZorg Aalst

Aalst, 9300, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

KBC Split

Split, HR 21000, Croatia

RECRUITING

KBC Zagreb

Zagreb, 10000, Croatia

RECRUITING

Neuron Medical s.r.o.

Brno, Czech Republic, 639 00, Czechia

RECRUITING

Institut klinické a experimentální medicíny (IKEM)

Prague, Czech Republic, 140 21, Czechia

RECRUITING

Motol and Homolka University Hospital

Prague, 150 30, Czechia

RECRUITING

Vilnius University Hospital Santariskiu Klinikos

Vilnius, LT-08406, Lithuania

RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Steven McQuillan, BA

CONTACT

1-763-331-4344; smcquillan@argamedtech.com

Deana Pierce, BS

CONTACT

1-760-637-9109; dpierce@argamedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, multi-center

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); LI (1); CZ (3); US (18); BE (2); CR (2)