CLP-AF-004_Visualise Etiology of Recurrent AF after failed AF ablation
Research type
Research Study
Full title
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation
IRAS ID
239296
Contact name
Stephen Murray
Contact email
Sponsor organisation
Acutus Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Research Summary
Treatment for an irregular heart beat can be with medicines, electrical shocks or re-ablation therapy. Atrial fibrillation (AF) is caused by rapid impluses of electricity that comes from the upper chambers of the heart (left or right atrium). This new device allows the doctor to "map" the exact places the impulses are coming from in order to better target the best places for ablation.AF is among the most prevalent arrhythmias in the world today affecting approximately 1.5-2% of the general population. The age of patients with AF is steadily rising and now averages between 75 and 85 years of age. AF is associated with five-fold risk of stroke, a three-fold incidence of congestive hear failure and higher mortality.
The AcQMap High Resolution Imaging and Mapping System (AcQMap System) has been designed to provide information on cardiac dipole densities as a function of time and project that information on an image of a cardiac chamber. In this study, the AcQMap System will collect data from the AcQMap 3D Imaging and Mapping Catheter (AcQMap Catheter) to create anatomical reconstructions of the chamber(s) being mapped and to create dipole density maps on those reconstructions. These maps will then be used to identify mechanisms of AF, which can be targeted for ablation.
Eligible patients for this study must be over the age of 18 and have had no more than 2 previous left-atrial ablations for AF treatment in the past 24 months.
This study will take place in up to 15 sites in Europe and approximately 100 patients will participate.
The study will last for approximately 12 months and will have to visit the hospital 5 times during this period.
Summary of Results
Study Title: Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Recurrent Atrial Fibrillation Following a Failed AF Ablation (RECOVER AF) Who carried out the study:
Sponsor (and funded by):
• Acutus Medical, Inc.
Where the study took place:
United Kingdom:
• John Radcliffe Hospital (PI Dr. Timothy Betts)
• Royal Papworth Hospital NHS Foundation Trust (PI Dr. Andrew Grace)
• Freeman Hospital (PI Dr. Stephen Murray)
• James Cook University Hospital (PI Dr. Simon James)
• Royal Brompton Hospital (PI Prof. Tom Wong)
• Sheffield Teaching Hospital (PI Dr. Justin Lee)
Germany:
• Universitätsklinikum Hamburg-Eppendorf (PI Prof. Stephan Willems)
• Herzzentrum der Universität zu Köln (PI Prof. Daniel Steven)
• Klinikum Coburg (PI Dr. Sonia Busch)
The Netherlands:
• Erasmus MC (PI Dr. Tamas Szili-Torok)
• St. Antonius Hospital (PI Dr. Lucas Boersma)
Czech Republic:
• Na Homolce Hospital (PI Dr. Petr Neuzil)
Belgium:
• UZ Brussel (PI Prof. Carlo de Asmundis)
Canada:
• Southlake Regional Health Center PI Dr. Atul Verma)
Why was the research needed?
The study was designed to evaluate a new cardiac system for diagnosing abnormal electrical activity of the upper chambers of the heart and guide the physician in the treatment of fast heart rhythms know as atrial fibrillation. This new system had the ability to show the physician areas in the heart that are causing the atrial fibrillation.
Who participated in the study:
Out of the 106 patient who qualified for treatment, 28 were female and 78 were male.
What treatments or interventions did the participants take/receive?
Ablation procedure
What medical problems (adverse reactions) did the participants have?:
There were twenty-five (25) adverse reactions were reported in a total of twenty-one (21) subjects. Out of those only one was considered related to the device which was a hematoma (bad bruise). Additional detailed information can be found in clinicaltrials.gov.
The events consisted of the following:
• Pericarditis (swelling or irritation of the thin tissue surrounding the heart)
• Nausea
• Fever
• Groin pain
• Haematurie (blood in the urine)
• Haemoptysis (coughing of blood)
• Skin burn
• Tamponade (extra flued buildup in the space around the heart)
• Urine infection with urinary retention
• Arteriovenous fistula ((abnormal connection between artery and vein in which flood flows directly from an artery into a vein, bypassing some capillaries)
• Gallstone cholecystitis (inflamed gallbladder)
• Groin bleeding
• ST-Elevation V1-V3 (evidence of potential heart attack)
• Aneurysm spurium right groin (an abnormal bulge or ballooning in the wall of a blood vessel)
• Pericardial effusions (build up of too much fluid in the double-layered, saclike structure around the heart known as the perdicardium)
What happened during the study?:
A total of one-hundred and twenty-eight (128) patients were evaluated to be in the study and one-hundred and six (106) patients qualified to be treated by the system. Seventy -nine (79) of these patients were being treated for the second time and twenty-seven (27) were being treated for a third time for the same atrial fibrillation condition which came back after their previous therapy.
What were the results of the study?:
Eighty-four (84) patients had regions of the heart where the new system assisted doctors in identify locations for possible treatment. Other commercial systems do not have the technology to assist in finding these possible locations for treatment. A measure of success for this therapy is that the atrial fibrillation does not come back within one year. Of these one-hundred and six (106) patients treated with this new system, 71% (seventy-five (75)) patients did not have their atrial fibrillation return within 1 year of the study-based procedure. The results were similar between patients undergoing first vs. second retreatment. No major complications were reported as a result of using the new cardiac system.
How has this study helped patients and researchers?:
The new system has assisted researchers in determining where to perform ablations to treat the subject’s atrial fibrillation. This in turn enables a more personalized approach for potentially better outcomes.
Details on any further research planned:
There are currently 2 ongoing registry studies, 1 in the UK/EU and 1 in the US.
Where can I learn more about this study?:
Study doctor who treated you and Clinicaltrials.gov website.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0033
Date of REC Opinion
14 Feb 2018
REC opinion
Favourable Opinion