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

NCT04431544 | Terminated FDA Device

• 1 other identifier: CLP-20
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 25

Brief Summary

AcQMap Registry is an observation study

Conditions

Ablation of Arrhythmia's

Keywords

ablation; atrial arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Long-term Outcome

  3 years

Interventions

AcQMap System DEVICE

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Acutus Medical: lead

Study Sites (25)

Grandview Medical Group Research

Birmingham, Alabama, 35243, United States

Location

Banner University Medical Institute

Phoenix, Arizona, 85006, United States

Location

St Jude Medical Center

Fullerton, California, 92835, United States

Location

University California San Diego

La Jolla, California, 92037, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Mission Heritage Mission Viejo - Cardiac Electrophysiology

Mission Viejo, California, 92691, United States

Location

Eisenhower Medical Center

Rancho Mirage, California, 92270, United States

Location

Dignity Health Research Institute

Sacramento, California, 95819, United States

Location

Bethesda Hospital East

Boynton Beach, Florida, 33435, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Ascension St. Vincent's Medical Center Riverside

Jacksonville, Florida, 32204, United States

Location

Celebration Hospital

Orlando, Florida, 32803, United States

Location

Sarasota Memorial Research Institute

Sarasota, Florida, 34239, United States

Location

Bayfront (Orlando Health)

St. Petersburg, Florida, 33701, United States

Location

Saint Alphonsus Health System

Boise, Idaho, 83704, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Baptist Lexington Medical Center

Lexington, Kentucky, 40503, United States

Location

Henry Ford Health Center

Detroit, Michigan, 48202, United States

Location

Nevada Heart and Vascular

Las Vegas, Nevada, 89118, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Weill Cornell Medicine, New York Presbyterian Hospital

New York, New York, 10021, United States

Location

ProMedica Physician Cardiology

Toledo, Ohio, 43606, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78750, United States

Location

Methodist Healthcare

San Antonio, Texas, 78249, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: September 29, 2020
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (25)