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

NCT ID: NCT04431544

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

513 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-29

Study Completion Date

2023-11-08

Brief Summary

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AcQMap Registry is an observation study

Detailed Description

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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.

Conditions

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Ablation of Arrhythmia's

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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AcQMap System

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).

Intervention Type DEVICE

Eligibility Criteria

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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.).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acutus Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grandview Medical Group Research

Birmingham, Alabama, United States

Site Status

Banner University Medical Institute

Phoenix, Arizona, United States

Site Status

St Jude Medical Center

Fullerton, California, United States

Site Status

University California San Diego

La Jolla, California, United States

Site Status

Keck School of Medicine of USC

Los Angeles, California, United States

Site Status

Mission Heritage Mission Viejo - Cardiac Electrophysiology

Mission Viejo, California, United States

Site Status

Eisenhower Medical Center

Rancho Mirage, California, United States

Site Status

Dignity Health Research Institute

Sacramento, California, United States

Site Status

Bethesda Hospital East

Boynton Beach, Florida, United States

Site Status

Clearwater Cardiovascular Consultants

Clearwater, Florida, United States

Site Status

Ascension St. Vincent's Medical Center Riverside

Jacksonville, Florida, United States

Site Status

Celebration Hospital

Orlando, Florida, United States

Site Status

Sarasota Memorial Research Institute

Sarasota, Florida, United States

Site Status

Bayfront (Orlando Health)

St. Petersburg, Florida, United States

Site Status

Saint Alphonsus Health System

Boise, Idaho, United States

Site Status

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Site Status

Baptist Lexington Medical Center

Lexington, Kentucky, United States

Site Status

Henry Ford Health Center

Detroit, Michigan, United States

Site Status

Nevada Heart and Vascular

Las Vegas, Nevada, United States

Site Status

Morristown Medical Center

Morristown, New Jersey, United States

Site Status

Weill Cornell Medicine, New York Presbyterian Hospital

New York, New York, United States

Site Status

ProMedica Physician Cardiology

Toledo, Ohio, United States

Site Status

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Site Status

Methodist Healthcare

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CLP-20

Identifier Type: -

Identifier Source: org_study_id

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