Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

Study Overview
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Brief Summary
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Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter Phased RFA) System in a real world patient population with atrial fibrillation (AF) and evaluate its performance. Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

Detailed Description
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This registry will collect data prospectively on patients with paroxysmal, persistent and longstanding persistent atrial fibrillation (hereafter AF) undergoing Phased RFA treatment. Phased RFA will be applied according to the 'Intended Use' in CE mark (European Conformity) release and product packaging. The treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. This registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the Medtronic Phased RFA System in a real world patient population. The key measures collected for the patients will be inclusive of, but are not limited to, clinical data pertaining to AF and individual disease state(s) characterized by form of AF and underline diseases, Phased RFA procedure details including timing and catheters in use, procedure and system related adverse events, AF recurrence, re-ablations and left atrial flutter rate after the index Phased RFA procedure. Additionally, this study will provide further information in the evolving anticoagulation strategies (e.g. continuous versus bridging and vitamin K antagonist versus novel oral anticoagulants) in the setting of AF ablations. Patients will be followed minimum for 12 months and maximum for 14 months after the Phased RFA ablation procedure. The twelve month follow-up can be done by telephone if it is not standard of care in the hospital's practice. During the twelve month follow-up patients will be interviewed with a quality of life questionnaire and results will be compared to the quality of life questionaire completed before the procedure.

Official Title
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Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient with AF who is scheduled for Phased RFA procedure Patient signed patient informed consent or patient data release form Age ≥18 years old To avoid enrollment bias in this cohort of patient and reflect real world clinical practice for Phased RFA no exclusion criteria will be defined.

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate Phased RFA (Radio Frequency Ablation) Mid-term Success Rate | Success rate will be estimated as time to first event: AF recurrence and/or left Atrial Flutter. Parameters of interest include: re-ablations, ECG/EGM (electrogram) recorded AF, electrical and pharmacological cardioversions. | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate Phased RFA Mid-term Safety | Estimate major procedure/system related complications of Phased RFA | Patient will be followed for minimum 12 months, maximum 14 months after index Phased RFA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Vein Isolation, Phased Radiofrequency Ablation