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

AcQMap Registry is an observation study

Study Overview

• Status: Terminated
• Conditions: Ablation of Arrhythmia's
• Intervention / Treatment: Device: AcQMap System

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.

• Study Type: Observational
• Enrollment (Actual): 513

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Group Research
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Institute
  • California
    • Fullerton, California, United States, 92835
      • St Jude Medical Center
    • La Jolla, California, United States, 92037
      • University California San Diego
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • Mission Viejo, California, United States, 92691
      • Mission Heritage Mission Viejo - Cardiac Electrophysiology
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
    • Sacramento, California, United States, 95819
      • Dignity Health Research Institute
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Bethesda Hospital East
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Jacksonville, Florida, United States, 32204
      • Ascension St. Vincent's Medical Center Riverside
    • Orlando, Florida, United States, 32803
      • Celebration Hospital
    • Saint Petersburg, Florida, United States, 33701
      • Bayfront (Orlando Health)
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Research Institute
  • Idaho
    • Boise, Idaho, United States, 83704
      • Saint Alphonsus Health System
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Kansas City Heart Rhythm Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Lexington Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health Center
  • Nevada
    • Las Vegas, Nevada, United States, 89118
      • Nevada Heart and Vascular
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine, New York Presbyterian Hospital
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Physician Cardiology
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-0850
      • Penn State Health Milton S. Hershey Medical Center
  • Texas
    • Austin, Texas, United States, 78750
      • Texas Cardiac Arrhythmia Research Foundation
    • San Antonio, Texas, United States, 78249
      • Methodist Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.

Description

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.).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Acutus Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ablation; atrial arrhythmia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CLP-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No