AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
- Conditions
- Ablation of Arrhythmia's
- Registration Number
- NCT03893331
- Lead Sponsor
- Acutus Medical
- Brief Summary
AcQMap Registry is an observational study
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 479
- Male or female 18 years of age or older.
- Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
- Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
- Willing and able to give written informed consent.
- In the opinion of the Investigator, any known contraindications to an ablation procedure.
- Current enrollment in any study protocol sponsored by Acutus Medical.
- Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Procedural Ablation Outcomes 12 hours • 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
- Secondary Outcome Measures
Name Time Method Long-term Outcome 3 years • 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).
Trial Locations
- Locations (12)
Erasmus MC Cardiologie Elektrofysiologie
🇳🇱Rotterdam, Netherlands
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Klinikum Coburg
🇩🇪Coburg, Germany
I.C.P.S. Hôspital Privé Jacques Cartier
🇫🇷Paris, France
James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
St. George's Hospital
🇬🇧London, United Kingdom
Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Sheffield Teaching Hospital Northern General Hospital
🇬🇧Sheffield, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom