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

Ablation of Arrhythmia's Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04431544
• Other study ID #: CLP-20
• Status: Terminated
• Start date: September 29, 2020
• 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 observation study

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 513
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Sponsors (1)

Lead Sponsor	Collaborator
Acutus Medical

Country where clinical trial is conducted

United States, 

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 or another arrhythmia 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