Recurrent Atrial FibrillationRECOVER AFNCT03368781
AcQMap Objectively Visualize the Etiology of Recurrent AF Following a Failed AF Ablation
A study testing AcQMap Imaging and Mapping System in people with Recurrent Atrial Fibrillation, run by Acutus Medical at 15 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 High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Atrial Fibrillation
- What is being tested?
- AcQMap Imaging and Mapping System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 12 Apr 2018to 29 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female eighteen (18) years of age or older
- Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed ≤ twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF
Who cannot join
- No more than two (2) previous left-atrial ablations
- Structural heart disease or implanted cardiac devices
- History of blood clotting or bleeding disease
- Pregnant or lactating (current or anticipated during study follow up)
- Evidence of left atrial thrombus
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
United Kingdom6 sites
Papworth Hospital NHS
Cambridge, CB38RE
Royal Brompton Hospital
London, Sw3 6NP
James Cook University Hospital
Middlesbrough, TS4 3BW
Freeman Hospital
Newcastle, NE7 7DN
John Radcliffe Hospital
Oxford, OX3 9DU
Sheffield Teaching Hospital Northern
Sheffield
Germany4 sites
Klinikum Coburg
Coburg, 96450
Klinikum Coburg
Coburg
Herzzentrum der Universität zu Köln
Cologne, D-50937
Universitätsklinikum Hamburg-Eppendorf
Hamburg, D - 20246
Netherlands2 sites
St. Antonius Hospital
Nieuwegein, 3435 CM
Erasmus MC
Rotterdam, 3015 CE
Belgium1 site
UZ Brussel Centrum voor Hart-en Vaatziekten
Belsele, Jette, 1090
About this study
Official title: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER 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 High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-004 [EU])
A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-005 [Canada])
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 High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-004 [EU])
A prospective, single-arm, multi-center, multi-national, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-005 [Canada])
- Conditions
- Recurrent Atrial Fibrillation
- Being tested
- AcQMap Imaging and Mapping System
- Keywords
- Atrial Fibrillation
- 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 Imaging and Mapping SystemDevice
Also called AcQMap
3D Cardiac Imaging and Mapping during ablation procedures
| Study group | Role | What they receive |
|---|---|---|
| AcQMap Imaging and Mapping | Experimental | Use of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. Receives: Device: AcQMap Imaging and Mapping System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets
At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap System
Measured: 12 hours
Secondary outcomes (6)
Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure
Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 6-months as measured by a 48-hour continuous ECG
Measured: 6 months
Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out
Documentation of procedure data including total time
Measured: 4 hours
Procedure Performance: Total Fluoroscopy Time
Documentation of procedure data including fluoroscopy time
Measured: 4 hours
Procedure Performance: Ablation Times for PVI
Documentation of procedure data including ablation times for PVI
Measured: 2 hours
Procedure Performance: Ablation Times for Non-PV Targets
Documentation of procedure data including ablation times for non-PV targets
Measured: 2 hours
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure
Recording of all subjects who are atrial fibrillation free from events lasting > 30 seconds at 12-months as measured by a 48-hour continuous ECG
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start12 Apr 2018
- Primary completion29 Oct 2020
- Study completion29 Oct 2020
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.
- Other trials for Recurrent 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
- Model description
- None randomized, single-arm, open label.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acutus Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Grace, MD, Principal investigator, Papworth Hospital NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368781
- Sponsor's protocol ID
- CLP-AF-004
- Other IDs
- CLP-AF-005, CLP-AF-004-NL
- Acronym
- RECOVER AF
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2017
- Last updated
- 27 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. 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 Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF)
- ClinicalTrials.gov ID
- NCT03368781
- Acronym / sponsor ID
- RECOVER AF / CLP-AF-004
- Conditions
- Recurrent Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Acutus MedicalIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 29 Oct 2020 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 12 Apr 2022
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 High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-004 [EU])
A prospective, single-arm, multi-center, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. (CLP-AF-005 [Canada])
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 High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-004 [EU])
A prospective, single-arm, multi-center, multi-national, non-randomized, pre-market study designed to provide clinical data regarding the use of the AcQMap High Resolution Imaging and Mapping System during an atrial fibrillation retreatment ablation procedure. The patient population includes men and women, eighteen (18) years of age or older. The treatment plan must include evaluation and ablation (as indicated) of pulmonary vein reconnections plus AcQMap guided non-PV substrate ablation. Subject assessments will occur at screening, procedure, hospital discharge, 3-, 6-, and 12-months. (CLP-AF-005 [Canada])
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- None randomized, single-arm, open label.
| Arm | Type | Receives |
|---|---|---|
| AcQMap Imaging and Mapping | Experimental | Device: AcQMap Imaging and Mapping SystemUse of the AcQMap Imaging and Mapping System as a diagnostic modality in an ablation retreatment procedure for recurrent atrial fibrillation following a failed AF ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female eighteen (18) years of age or older
- Currently scheduled for a repeat endocardial ablation of AF where the index atrial fibrillation ablation procedure was completed ≤ twenty-four (24) months prior to enrollment and the subject has demonstrated at least one episode of post-ablation non-self-terminating AF
Key exclusion criteria (5 listed)
- No more than two (2) previous left-atrial ablations
- Structural heart disease or implanted cardiac devices
- History of blood clotting or bleeding disease
- Pregnant or lactating (current or anticipated during study follow up)
- Evidence of left atrial thrombus
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 Imaging and Mapping SystemAlso: AcQMap3D Cardiac Imaging and Mapping during ablation procedures | Device | AcQMap Imaging and Mapping |
Primary outcome
Number of Participants With Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets
Time frame: 12 hours
At the procedure conclusion, confirmation of electrical isolation of all pulmonary veins and elimination/modification of all non-PV targets as identified by the AcQMap System
6 secondary outcomes
Number of Subjects Who Are Atrial Fibrillation Free at 6 Months Post Procedure
Time frame: 6 months
Procedure Performance: Total Procedure Time Defined as First Venous Access to Last Cardiac Catheter Out
Time frame: 4 hours
Procedure Performance: Total Fluoroscopy Time
Time frame: 4 hours
Procedure Performance: Ablation Times for PVI
Time frame: 2 hours
Procedure Performance: Ablation Times for Non-PV Targets
Time frame: 2 hours
Number of Subjects Who Are Atrial Fibrillation Free at 12 Months Post Procedure
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Recurrent Atrial Fibrillation
Not yet recruitingPhase 4
Sacubitril/Valsartan vs Standard Treatment for Preventing Atrial Fibrillation Recurrence After Catheter Ablation in Persistent Atrial Fibrillation Patients With Without Hypertension
Atrial Fibrillation (Persistent), Catheter Ablation
RecruitingObservational study
Atrial Fibrillation Patients Treated With Catheter Ablation
Atrial Fibrillation, Atrial Fibrillation Recurrent
RecruitingObservational study
BOdygUardian MOnitoriNg for ReCurrencE of AF
Atrial Fibrillation (AF)
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
Active, not recruiting
The Effect of Low-Level Tragus Stimulation on Inflammation and Early Recurrence After Pulsed Field Ablation: A Randomized Controlled Study
Atrial Fibrillation
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.
Andrew Grace, MD principal investigator
Papworth Hospital NHS
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcQMap Imaging and Mapping System in people with Recurrent Atrial Fibrillation, run by Acutus Medical at 15 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 2 inclusion and 5 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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom, Germany, Netherlands, Belgium, Canada 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 12 Apr 2022). 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 Confirmation of Electrical Isolation of All Pulmonary Veins and Elimination/Modification of All Non-PV Targets (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 27 Jul 2022.