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

• Sponsor: Acutus Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05181878
• Collaborator: (none)
• Enrollment: 15
• Locations: 4
• Anticipated Duration (Months): 11
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Ablation	Device: The AcQMap 2.1 System with Electro-Magnetic Tracking Feasibility System

Detailed Description

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)
• Actual Study Start Date: Dec 29, 2021
• Anticipated Primary Completion Date: Nov 30, 2022
• Anticipated Study Completion Date: Nov 30, 2022

Outcome Measures

Primary Outcome Measures

1. Successful recording of continuous and synchronized impedance and magnetic localization information. [Procedure]

   Successful recording of continuous and synchronized impedance and magnetic localization information.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kansas City Heart Rhythm Institute	Overland Park	Kansas	United States	66211
2	Nevada Heart and Vascular	Las Vegas	Nevada	United States	89118
3	Jessa Ziekenhuis	Hasselt		Belgium	3500
4	UZ Brussel	Jette		Belgium	1090

Sponsors and Collaborators

• Acutus Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Acutus Medical
• ClinicalTrials.gov Identifier: NCT05181878
• Other Study ID Numbers: CLP-24 US; CLP-24 (EU)
• First Posted: Jan 6, 2022
• Last Update Posted: Jun 10, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Acutus Medical: localization

Study Results

No Results Posted as of Jun 10, 2022