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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04431544

Enrollment

513

Registered

2020-06-16

Start date

2020-09-29

Completion date

2023-11-08

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ablation of Arrhythmia's

Keywords

ablation, atrial arrhythmia

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.

Interventions

DEVICEAcQMap 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).

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026