AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

NCT04431544 — Terminated, 513 participants, Acutus Medical

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RegistryNCT04431544
StatusTerminated - Sponsor no longer performing clinical studies. Will only be a manufacturer
Study typeObservational
Enrollment513 (Actual)
SponsorAcutus Medical (Industry)
ConditionsAblation of Arrhythmia's
InterventionsAcQMap System (Device)
Datesstart 2020-09-29, primary completion 2023-11-08, completion 2023-11-08, first posted 2020-06-16, last updated 2023-11-13
Locations25 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Ablation of Arrhythmia's All trials of AcQMap System

-Summary

AcQMap Registry is an observation study

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+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.

+Arms and interventions

  • 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).

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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).

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.).

+Locations (25)

FacilityCityCountryStatus
Grandview Medical Group ResearchBirmingham, AlabamaUnited States
Banner University Medical InstitutePhoenix, ArizonaUnited States
St Jude Medical CenterFullerton, CaliforniaUnited States
University California San DiegoLa Jolla, CaliforniaUnited States
Keck School of Medicine of USCLos Angeles, CaliforniaUnited States
Mission Heritage Mission Viejo - Cardiac ElectrophysiologyMission Viejo, CaliforniaUnited States
Eisenhower Medical CenterRancho Mirage, CaliforniaUnited States
Dignity Health Research InstituteSacramento, CaliforniaUnited States
Bethesda Hospital EastBoynton Beach, FloridaUnited States
Clearwater Cardiovascular ConsultantsClearwater, FloridaUnited States
Ascension St. Vincent's Medical Center RiversideJacksonville, FloridaUnited States
Celebration HospitalOrlando, FloridaUnited States
Sarasota Memorial Research InstituteSarasota, FloridaUnited States
Bayfront (Orlando Health)St. Petersburg, FloridaUnited States
Saint Alphonsus Health SystemBoise, IdahoUnited States
Kansas City Heart Rhythm InstituteOverland Park, KansasUnited States
Baptist Lexington Medical CenterLexington, KentuckyUnited States
Henry Ford Health CenterDetroit, MichiganUnited States
Nevada Heart and VascularLas Vegas, NevadaUnited States
Morristown Medical CenterMorristown, New JerseyUnited States
Weill Cornell Medicine, New York Presbyterian HospitalNew York, New YorkUnited States
ProMedica Physician CardiologyToledo, OhioUnited States
Penn State Health Milton S. Hershey Medical CenterHershey, PennsylvaniaUnited States
Texas Cardiac Arrhythmia Research FoundationAustin, TexasUnited States
Methodist HealthcareSan Antonio, TexasUnited States