AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
- Conditions
- Ablation of Arrhythmia's
- Registration Number
- NCT04431544
- Lead Sponsor
- Acutus Medical
- Brief Summary
AcQMap Registry is an observation study
- Detailed Description
AcQMap Registry is an observational, prospective, multi-center, 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
- 513
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 or another arrhythmia 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 (25)
Clearwater Cardiovascular Consultants
🇺🇸Clearwater, Florida, United States
Methodist Healthcare
🇺🇸San Antonio, Texas, United States
Kansas City Heart Rhythm Institute
🇺🇸Overland Park, Kansas, United States
Banner University Medical Institute
🇺🇸Phoenix, Arizona, United States
Henry Ford Health Center
🇺🇸Detroit, Michigan, United States
Grandview Medical Group Research
🇺🇸Birmingham, Alabama, United States
Sarasota Memorial Research Institute
🇺🇸Sarasota, Florida, United States
St Jude Medical Center
🇺🇸Fullerton, California, United States
University California San Diego
🇺🇸La Jolla, California, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Mission Heritage Mission Viejo - Cardiac Electrophysiology
🇺🇸Mission Viejo, California, United States
Bethesda Hospital East
🇺🇸Boynton Beach, Florida, United States
Ascension St. Vincent's Medical Center Riverside
🇺🇸Jacksonville, Florida, United States
Bayfront (Orlando Health)
🇺🇸Saint Petersburg, Florida, United States
Saint Alphonsus Health System
🇺🇸Boise, Idaho, United States
Baptist Lexington Medical Center
🇺🇸Lexington, Kentucky, United States
Nevada Heart and Vascular
🇺🇸Las Vegas, Nevada, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Weill Cornell Medicine, New York Presbyterian Hospital
🇺🇸New York, New York, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
ProMedica Physician Cardiology
🇺🇸Toledo, Ohio, United States
Dignity Health Research Institute
🇺🇸Sacramento, California, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Celebration Hospital
🇺🇸Orlando, Florida, United States