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Sponsor no longer performing clinical studies. Will be only a manufacturing facility
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AcQMap Registry is an observational study
AcQMap Registry is an observational, prospective, multi-center, multi-national, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcQMap System | Device | To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU). |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Ablation Outcomes | • Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Outcome | • First-procedure freedom from any arrhythmia on and/or off AADs, throughout the follow-up period, excluding events in the initial 90 days following the procedure (blanking period). | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
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| Name | Affiliation | Role |
|---|---|---|
| Simon James, MD | James Cook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.C.P.S. Hôspital Privé Jacques Cartier | Paris | France | ||||
| Klinikum Coburg |
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| Coburg |
| Germany |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 | Netherlands |
| Erasmus MC Cardiologie Elektrofysiologie | Rotterdam | 3015 CE | Netherlands |
| Papworth Hospital NHS Foundation Trust | Cambridge | CB38RE | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| St. George's Hospital | London | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Sheffield Teaching Hospital Northern General Hospital | Sheffield | S57AU | United Kingdom |