Coherent Sine Burst Electroporation (CSE) Ablation System US Investigational Device Exemption (IDE) Study for Patients With Atrial Fibrillation
Arga Medtech SA
Summary
To evaluate the safety and effectiveness of the Argá Medtech CSE Ablation System in the treatment of atrial fibrillation.
Description
A prospective, multi-center, non-randomized, unblinded pre-market study designed to provide clinical data to support regulatory approval of the Argá Medtech CSE Ablation System for the ablation of atrial fibrillation and adjunctive use for additional atrial ablation. Patients with a history of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) or persistent atrial fibrillation (PersAF) will, at a minimum, undergo ablative intervention of the pulmonary veins.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients between the ages of 18 and 80 years, or older than 18 if required by local law. 2. 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 th…
Interventions
- DeviceArgá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Ablation using the Argá Medtech Coherent Sine-Burst Electroporation (CSE) Ablation System
Locations (27)
- GrandviewBirmingham, Alabama
- Banner University Med CtrPhoenix, Arizona
- Arrhythmia Research GroupJonesboro, Arkansas
- UCSDSan Diego, California
- Ascension / St. Vincent's JacksonvilleJacksonville, Florida
- Advent HealthOrlando, Florida