Ablation of Arrhythmia'sNCT04431544
AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
An observational study of Ablation of Arrhythmia's, run by Acutus Medical at 25 sites in United States.
Trial summary
AcQMap Registry is an observation study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ablation of Arrhythmia's
- What is being tested?
- AcQMap System
- Type of treatment
- Medical device
- How many people
- 513 participants
- Where
- 25 sitesUnited States
- Study dates
- 29 Sep 2020to 8 Nov 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78750
Grandview Medical Group Research
Birmingham, Alabama, 35243
Saint Alphonsus Health System
Boise, Idaho, 83704
Bethesda Hospital East
Boynton Beach, Florida, 33435
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Henry Ford Health Center
Detroit, Michigan, 48202
St Jude Medical Center
Fullerton, California, 92835
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Ascension St. Vincent's Medical Center Riverside
Jacksonville, Florida, 32204
University California San Diego
La Jolla, California, 92037
Nevada Heart and Vascular
Las Vegas, Nevada, 89118
Baptist Lexington Medical Center
Lexington, Kentucky, 40503
Keck School of Medicine of USC
Los Angeles, California, 90033
Mission Heritage Mission Viejo - Cardiac Electrophysiology
Mission Viejo, California, 92691
Morristown Medical Center
Morristown, New Jersey, 07960
Weill Cornell Medicine, New York Presbyterian Hospital
New York, New York, 10021
Celebration Hospital
Orlando, Florida, 32803
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Banner University Medical Institute
Phoenix, Arizona, 85006
Eisenhower Medical Center
Rancho Mirage, California, 92270
Dignity Health Research Institute
Sacramento, California, 95819
Methodist Healthcare
San Antonio, Texas, 78249
Sarasota Memorial Research Institute
Sarasota, Florida, 34239
Bayfront (Orlando Health)
St. Petersburg, Florida, 33701
ProMedica Physician Cardiology
Toledo, Ohio, 43606
About this study
AcQMap Registry is an observation study
Read the detailed 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.
- Conditions
- Ablation of Arrhythmia's
- Being tested
- AcQMap System
- Keywords
- ablation, atrial arrhythmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcQMap SystemDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours
Secondary outcomes (1)
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start29 Sep 2020
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Why it stopped: Sponsor no longer performing clinical studies. Will only be a manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ablation of Arrhythmia'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431544
- Sponsor's protocol ID
- CLP-20
- Status last verified
- Nov 2023
- First submitted
- 11 Jun 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)
- ClinicalTrials.gov ID
- NCT04431544
- Acronym / sponsor ID
- CLP-20
- Conditions
- Ablation of Arrhythmia's
- Keywords
- ablation, atrial arrhythmia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor no longer performing clinical studies. Will only be a manufacturer
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AcQMap Registry is an observation study
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcQMap SystemTo 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). | Device | – |
Primary outcome
Procedural Ablation Outcomes
Time frame: 12 hours
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
1 secondary outcome
Long-term Outcome
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Sponsor no longer performing clinical studies. Will only be a manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Ablation of Arrhythmia's
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ablation of Arrhythmia's, run by Acutus Medical at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor no longer performing clinical studies. Will only be a manufacturer). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Ablation Outcomes (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.