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The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Patients enrolled and treated with the Affera Platform |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Affera Platform | Device | A cardiac ablation will be performed using the Affera Platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective #1 (Efficacy) | Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform. | 12 Month Post Proceedure |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective #2 (Safety) | Estimate serious device and serious procedure-related adverse events for the Affera Platform. | 90 Days Post Proceedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for an ablation with the Affera Platform may be approached regarding enrollment in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Libby Bergmann | Contact | libby.bergmann@medtronic.com | libby.bergmann@medtronic.com | |
| Susan Knols | Contact | susan.knols@medtronic.com | susan.knols@medtronic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Brussels | 1090 | Belgium |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| IKEM - Institut Klinické a Experimentální Medicíny | Recruiting | Prague | 14021 | Czechia |
|
| Nemocnice Na Homolce | Recruiting | Prague | 15030 | Czechia |
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| Hôpital Haut-Lévêque - CHU de Bordeaux | Recruiting | Bordeaux | 33604 | France |
|
| Clinique Pasteur | Recruiting | Toulouse | 31076 | France |
|
| Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte | Recruiting | Berlin | 10117 | Germany |
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| MVZ CCB Frankfurt und Main Taunus GbR | Recruiting | Frankfurt | 60431 | Germany |
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| Universitäres Herzzentrum | Recruiting | Hamburg | 20246 | Germany |
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| Beacon Hospital | Recruiting | Dublin | D18 AK68 | Ireland |
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| Inselspital - Universitätsspital Bern | Recruiting | Bern | 3010 | Switzerland |
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| Royal Papworth Hospital NHS Foundation Trust | Recruiting | Cambridge | CB2 0AY | United Kingdom |
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| Imperial College Healthcare NHS Trust - Hammersmith Hospital | Recruiting | London | W12 0HS | United Kingdom |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |