Coherent Sine Burst Electroporation (CSE) Ablation System US IDE Study for Patients With Atrial Fibrillation
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Arga Medtech SA
- Study ID
- NCT06784466
- Status
- Recruiting
Conditions
- Atrial Fibrillation (AF)
- Paroxysmal AF
- Persistant Atrial Fibrillation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System — DEVICEAblation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Study Details
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Key Dates
- Start date
- Sep 10, 2025
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 360 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Paroxysmal AFPatients with paroxysmal AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
- Experimental: Persistent AFPatients with persistent AF will receive treatment using the Arga Medtech Coherent Sine-Burst Electroporation ablation system to achieve pulmonary vein isolation.
Primary Outcome Measure
Safety: Number of Participants With at Least One Primary Safety Event. [ Time Frame: Up to 180 days ]
Central Contacts
- Steven McQuillan, BA1-763-331-4344
- Deana Pierce, BS1-760-637-9109
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Grandview | Birmingham | Alabama | 35243 | Anil Rajendra, MD Anil Rajendra, MD (PRINCIPAL_INVESTIGATOR) |
| Banner University Med Ctr | Phoenix | Arizona | 85006 | Rong Bai, MD Stephanie Marsh Rong Bai, MD (PRINCIPAL_INVESTIGATOR) |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | Devi Nair, MD Chris Prather Devi Nair, MD (PRINCIPAL_INVESTIGATOR) |
| UCSD | San Diego | California | 92037-7411 | Jonathan Hsu, MD Jesus Gil Jonathan Hsu, MD (PRINCIPAL_INVESTIGATOR) |
| Ascension / St. Vincent's Jacksonville | Jacksonville | Florida | 32204 | Saumil Oza, MD Arianna Wright Saumil Oza, MD (PRINCIPAL_INVESTIGATOR) |
| Advent Health | Orlando | Florida | 32803 | Naushad Shaik, MD (PRINCIPAL_INVESTIGATOR) |
| Emory | Atlanta | Georgia | 30322 | David De Lurgio, MD (PRINCIPAL_INVESTIGATOR) |
| Northside Hospital | Atlanta | Georgia | 30342 | Alok Gambhir, MD Gambhir Alok Gambhir, MD (PRINCIPAL_INVESTIGATOR) |
| Prairie Education & Research Cooperative | Springfield | Illinois | 62769 | Ziad Issa, MD Lauren McNeil Ziad Issa, MD (PRINCIPAL_INVESTIGATOR) |
| Kansas City Heart Rhythm Institute (KCHRI) | Overland Park | Kansas | 66212 | Dhanunjaya Lakkireddy, MD Dhanunjaya Lakkireddy, MD (PRINCIPAL_INVESTIGATOR) |
| Baptist Health Lexington | Lexington | Kentucky | 30322 | Gery Tomassoni, MD Franklin Echevarria Gonzalez Gery Tomassoni, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | Michael Ghannam, MD Kirsta Bray Michael Ghannam, MD (PRINCIPAL_INVESTIGATOR) |
| TriHealth Cincinnati | Cincinnati | Ohio | 45202 | Emile Daoud, MD Tia Little Emile Daoud, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Walid Saliba, MD Walid Saliba, MD (PRINCIPAL_INVESTIGATOR) |
| Ohio Health Research and Innovation Institute | Columbus | Ohio | 43214 | Anish Amin, MD Anish Amin, MD (PRINCIPAL_INVESTIGATOR) |
| Trident Medical Center | Charleston | South Carolina | 29406 | Franklin Cuoco, MD Franklin Cuoco, MD (PRINCIPAL_INVESTIGATOR) |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | Andrea Natale, MD (PRINCIPAL_INVESTIGATOR) |
| Methodist | San Antonio | Texas | 78229 | David Pederson, MD David Pederson, MD (PRINCIPAL_INVESTIGATOR) |
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