Atrial Fibrillation Ablation Pilot Study

Study Overview
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Brief Summary
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This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.

Detailed Description
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The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including roll-in or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system. Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.

Official Title
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Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Ablation procedure and/or cardioversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of symptomatic permanent atrial fibrillation Age between 18 and 70 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study Exclusion Criteria: Structural heart disease of clinical significance Any prior ablation for atrial fibrillation Prior ablation for arrhythmias other than AF within the past three months Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study Active infection or sepsis Any history of cerebral vascular disease including stroke or TIAs Pregnancy or lactation Left atrial thrombus at the time of ablation Untreatable allergy to contrast media Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes History of blood clotting (bleeding or thrombotic) abnormalities Known sensitivities to heparin or warfarin Severe COPD (identified by an FEV1 < 1) Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ablation Management | Procedure: Ablation procedure and/or cardioversion<br>* Ablation Frontiers Cardiac Ablation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation