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Sponsor no longer performing clinical studies. Will only be a manufacturer
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AcQMap Registry is an observation study
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.
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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 or another arrhythmia 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:
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.
Exclusion Criteria:
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.).
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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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grandview Medical Group Research | Birmingham | Alabama | 35243 | United States | ||
| Banner University Medical Institute |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| St Jude Medical Center | Fullerton | California | 92835 | United States |
| University California San Diego | La Jolla | California | 92037 | United States |
| Keck School of Medicine of USC | Los Angeles | California | 90033 | United States |
| Mission Heritage Mission Viejo - Cardiac Electrophysiology | Mission Viejo | California | 92691 | United States |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | United States |
| Dignity Health Research Institute | Sacramento | California | 95819 | United States |
| Bethesda Hospital East | Boynton Beach | Florida | 33435 | United States |
| Clearwater Cardiovascular Consultants | Clearwater | Florida | 33756 | United States |
| Ascension St. Vincent's Medical Center Riverside | Jacksonville | Florida | 32204 | United States |
| Celebration Hospital | Orlando | Florida | 32803 | United States |
| Sarasota Memorial Research Institute | Sarasota | Florida | 34239 | United States |
| Bayfront (Orlando Health) | St. Petersburg | Florida | 33701 | United States |
| Saint Alphonsus Health System | Boise | Idaho | 83704 | United States |
| Kansas City Heart Rhythm Institute | Overland Park | Kansas | 66211 | United States |
| Baptist Lexington Medical Center | Lexington | Kentucky | 40503 | United States |
| Henry Ford Health Center | Detroit | Michigan | 48202 | United States |
| Nevada Heart and Vascular | Las Vegas | Nevada | 89118 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Weill Cornell Medicine, New York Presbyterian Hospital | New York | New York | 10021 | United States |
| ProMedica Physician Cardiology | Toledo | Ohio | 43606 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78750 | United States |
| Methodist Healthcare | San Antonio | Texas | 78249 | United States |