Clinical trial NCT04431544: AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
Official title: AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ablation of Arrhythmia's
Keywords: ablation
atrial arrhythmia
Lead sponsor: Acutus Medical
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Procedural Ablation Outcomes
timeFrame: 12 hours
Secondary outcomes:
measure: Long-term Outcome
timeFrame: 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Group Research
state: Alabama
city: Phoenix
country: United States
facility: Banner University Medical Institute
state: Arizona
city: Fullerton
country: United States
facility: St Jude Medical Center
state: California
city: La Jolla
country: United States
facility: University California San Diego
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Mission Viejo
country: United States
facility: Mission Heritage Mission Viejo - Cardiac Electrophysiology
state: California
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Sacramento
country: United States
facility: Dignity Health Research Institute
state: California
city: Boynton Beach
country: United States
facility: Bethesda Hospital East
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Jacksonville
country: United States
facility: Ascension St. Vincent's Medical Center Riverside
state: Florida
city: Orlando
country: United States
facility: Celebration Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Bayfront (Orlando Health)
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Research Institute
state: Florida
city: Boise
country: United States
facility: Saint Alphonsus Health System
state: Idaho
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Lexington
country: United States
facility: Baptist Lexington Medical Center
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Health Center
state: Michigan
city: Las Vegas
country: United States
facility: Nevada Heart and Vascular
state: Nevada
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medicine, New York Presbyterian Hospital
state: New York
city: Toledo
country: United States
facility: ProMedica Physician Cardiology
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare
state: Texas
Study officials:
References: