Persistent Atrial FibrillationUNCOVER-AFNCT02825992
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
A study testing AcQMap System in people with Persistent Atrial Fibrillation, run by Acutus Medical at 12 sites in 6 countries.
Trial summary
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- AcQMap System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 17 Oct 2016to 15 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Scheduled for an ablation of persistent atrial fibrillation
Who cannot join
- Any duration of continuous AF lasting longer than 12 months
- Previous AF ablation
- Significant structural heart disease
- Previous cerebral infarct
- Major bleeding disorders
- Pregnant or lactating
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United Kingdom4 sites
Papworth Hospital
Cambridge
Royal Brompton Hospital
London, SW3 6NP
Freeman Hospital
Newcastle, Newcastle Upon Tyne, NE7 7DN
John Radcliffe Hospital
Oxford, OX3 9DU
Germany3 sites
Vivantes Klinikum Am Urban
Berlin, 10967
Herzzentrum der Universität zu Köln
Cologne, D-50937
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Netherlands2 sites
Maastricht University Medical Center
Maastricht, 6229 HX
St. Antonius Hospital
Nieuwegein, 3435 CM
About this study
Official title: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
Read the detailed description
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows:
NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)
The above record was combined into one as both protocols are essentially identical (one is post market [EU] and the other pre-market [Canada] and one study report will be written that encompasses the data/results for both protocols.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- AcQMap System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcQMap SystemDevice
3D imaging and mapping system for cardiac chambers
| Study group | Role | What they receive |
|---|---|---|
| AcQMap System | Other | All patients who underwent catheter ablation using the AcQMap System Receives: Device: AcQMap System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.
Measured: 24 hours
Secondary outcomes (3)
Number of Participants Who Experienced at Least One Adverse Events.
Recording of all adverse events through 12 month follow-up
Measured: 12 Months
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.
Conversion to sinus rhythm post ablation
Measured: 24 hours
Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.
Freedom from AF
Measured: 6, 9, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start17 Oct 2016
- Primary completion30 Apr 2017
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Willems, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf (UKE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825992
- Sponsor's protocol ID
- CL-AF-002
- Other IDs
- CL-AF-001
- Acronym
- UNCOVER-AF
- Status last verified
- Jun 2020
- First submitted
- 5 Jul 2016
- Last updated
- 5 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willems S, Verma A, Betts TR, Murray S, Neuzil P, Ince H, Steven D, Sultan A, Heck PM, Hall MC, Tondo C, Pison L, Wong T, Boersma LV, Meyer C, Grace A. Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27.
PubMed 31242746
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation (UNCOVER-AF)
- ClinicalTrials.gov ID
- NCT02825992
- Acronym / sponsor ID
- UNCOVER-AF / CL-AF-002
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Posted 5 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
Detailed description
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
The research study was conducted in the EU and Canada. The protocol and the corresponding NCT number is as follows:
NCT02462980 (Protocol CL-AF-001, Site Ontario, Canada Dr. Verma = PI)
The above record was combined into one as both protocols are essentially identical (one is post market [EU] and the other pre-market [Canada] and one study report will be written that encompasses the data/results for both protocols.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AcQMap System | Other | Device: AcQMap SystemAll patients who underwent catheter ablation using the AcQMap System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for an ablation of persistent atrial fibrillation
Key exclusion criteria (6 listed)
- Any duration of continuous AF lasting longer than 12 months
- Previous AF ablation
- Significant structural heart disease
- Previous cerebral infarct
- Major bleeding disorders
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 System3D imaging and mapping system for cardiac chambers | Device | AcQMap System |
Primary outcome
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs)
Time frame: 24 hours
MAEs include: Death, cardiac perforation, cerebral infarct, systemic embolism, major bleeding, cardiac valve damage.
3 secondary outcomes
Number of Participants Who Experienced at Least One Adverse Events.
Time frame: 12 Months
Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure.
Time frame: 24 hours
Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation.
Time frame: 6, 9, and 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31242746Willems S, Verma A, Betts TR, Murray S, Neuzil P, Ince H, Steven D, Sultan A, Heck PM, Hall MC, Tondo C, Pison L, Wong T, Boersma LV, Meyer C, Grace A. Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. Circ Arrhythm Electrophysiol. 2019 Jul;12(7):e007233. doi: 10.1161/CIRCEP.119.007233. Epub 2019 Jun 27.
- Individual participant dataSharing planned: No
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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.
Stephan Willems, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf (UKE)
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcQMap System in people with Persistent Atrial Fibrillation, run by Acutus Medical at 12 sites in 6 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jun 2020. 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, Germany, Netherlands, Canada, Czechia and 1 more country. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825992, which also lists 1 linked publication.
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 5 Jun 2020.