AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-29

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Non-Significant Risk Clinical Study

Clinical Investigational Use Only for the purposes of collecting electromagnetic tracking data to validate the use of the device in a clinical setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

RESOLVE-AF: Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy.

NCT05883631

Atrial Fibrillation Atrial Fibrillation, Persistent Atrial Fibrillation Paroxysmal +6 more

ACTIVE_NOT_RECRUITING NA

A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter

NCT07116525

RECRUITING NA

A Study Assessing Arrhythmia Mapping With a Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter

NCT05373862

COMPLETED NA

Lattice-tip Versus Irrigated-tip Catheter for Linear Ablation of the Cavotricuspid Isthmus. A Multicenter, Randomized Study.

NCT07078760

Catheter Ablation

RECRUITING NA

Multimodal Image Processing Software to Guide Cardiac Ablation Therapy

NCT02275104

Ventricular Arrhythmias Persistent Atrial Fibrillation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The EMT Feasibility Study is a prospective, multi-center, feasibility study designed to demonstrate the feasibility of EMT solution in conjunction with the AcQMap 2.1 System's existing capabilities.

The objective of the study is to demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Catheter Ablation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The AcQMap 2.1 System with Electro-Magnetic Tracking Feasibility System

Demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female 18 years of age or older.
2. Currently scheduled for the ablation of an atrial arrhythmia utilizing the diagnostic AcQMap 2.1 System.
3. Willing and able to give written informed consent.

Exclusion Criteria

1. In the opinion of the investigator, any contraindication to the planned ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
2. Current enrollment in any study protocol sponsored by Acutus Medical
3. 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No