Ablation of Arrhythmia'sDISCOVERNCT03893331
AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
An observational study of Ablation of Arrhythmia's, run by Acutus Medical at 12 sites in 4 countries.
Trial summary
AcQMap Registry is an observational study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ablation of Arrhythmia's
- What is being tested?
- AcQMap System
- Type of treatment
- Medical device
- How many people
- 479 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 13 Jun 2019to 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 years and older
- 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
12 sites in 4 countries.
12 sites in 4 countries
United Kingdom8 sites
Papworth Hospital NHS Foundation Trust
Cambridge, CB38RE
Royal Brompton Hospital
London, SW3 6NP
St. George's Hospital
London
James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Norfolk and Norwich University Hospital
Norwich
John Radcliffe Hospital
Oxford, OX3 9DU
Sheffield Teaching Hospital Northern General Hospital
Sheffield, S57AU
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435
Erasmus MC Cardiologie Elektrofysiologie
Rotterdam, 3015 CE
About this study
AcQMap Registry is an observational study
Read the detailed 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.
- Conditions
- Ablation of Arrhythmia's
- Being tested
- AcQMap System
- Keywords
- Arrhythmia's
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 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 posted28 Mar 2019
- Study start13 Jun 2019
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Why it stopped: Sponsor no longer performing clinical studies. Will be only a manufacturing facility
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
- 479 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon James, MD, Principal investigator, James Cook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893331
- Sponsor's protocol ID
- CLP-AF-006
- Acronym
- DISCOVER
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2019
- 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® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
- ClinicalTrials.gov ID
- NCT03893331
- Acronym / sponsor ID
- DISCOVER / CLP-AF-006
- Conditions
- Ablation of Arrhythmia's
- Keywords
- Arrhythmia's
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor no longer performing clinical studies. Will be only a manufacturing facility
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 28 Mar 2019 (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 observational study
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- 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 (4 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 (3 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 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 be only a manufacturing facility). 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.
Simon James, MD principal investigator
James Cook University Hospital
12 sites in 4 countries: 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 12 sites in 4 countries.
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 4 inclusion and 3 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 12 sites in United Kingdom, Netherlands, France, Germany. 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 be only a manufacturing facility). 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.