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

Ablation of Arrhythmia's Clinical Trial

— DISCOVER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03893331
• Other study ID #: CLP-AF-006
• Status: Terminated
• Start date: June 13, 2019
• Est. completion date: November 8, 2023

Study information

• Verified date: November 2023
• Source: Acutus Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

AcQMap Registry is an observational study

Description:

AcQMap Registry is an observational, prospective, multi-center, multi-national, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 479
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.).

Related Conditions & MeSH terms

• Ablation of Arrhythmia's
• Arrhythmias, Cardiac

Intervention

Device:
• 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).

Locations

Country	Name	City	State
France	I.C.P.S. Hôspital Privé Jacques Cartier	Paris
Germany	Klinikum Coburg	Coburg
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Erasmus MC Cardiologie Elektrofysiologie	Rotterdam
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge
United Kingdom	Royal Brompton Hospital	London
United Kingdom	St. George's Hospital	London
United Kingdom	James Cook University Hospital	Middlesbrough
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Sheffield Teaching Hospital Northern General Hospital	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Countries where clinical trial is conducted

France,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Ablation Outcomes	• Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion	12 hours
Secondary	Long-term Outcome	• 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).	3 years