Mitral regurgitation is the most common heart valve disease in older adults. Affected patients typically undergo catheter-based repair of the defective valve. Many of these patients also have atrial fibrillation, a heart rhythm disorder that can be managed either with medication or with catheter ablation. Until now, however, no study has examined whether ablation offers any advantage over standard drug treatment once a mitral valve has been repaired.
Does ablation provide better protection against complications?
CABA-MiTRA stands for Catheter Ablation for Atrial Fibrillation in Patients with Severe Mitral Regurgitation after Successful Transcatheter Mitral Valve Repair. AFNET Board Member Prof. Stephan Willems of Hamburg, who is leading the CABA-MiTRA-AFNET12-DZHK34 study together with three AFNET Steering Committee members – Prof. Lars Eckardt of Münster, Prof. Daniel Steven of Cologne, and Prof. Reza Wakili of Frankfurt – explains the background:
“Recent findings showed that catheter ablation provides better protection against complications of atrial fibrillation for patients with atrial fibrillation and certain comorbidities than the usual standard treatment. We now want to determine whether this also applies to the specific group of atrial fibrillation patients who have undergone mitral valve repair. To this end, the Atrial Fibrillation Competence Network (AFNET) launched the CABA-MiTRA-AFNET12-DZHK34 study and is now conducting it in collaboration with the German Center for Cardiovascular Research (DZHK).“
To answer the study’s research question, AFNET plans to enroll 956 patients who have atrial fibrillation and have undergone successful mitral valve repair within the past six months. Upon enrollment in the study, all participants will be randomly assigned to one of two equally sized groups, where they will receive either atrial fibrillation ablation or standard guideline-based medical treatment. Approximately 50 hospitals in Germany and Europe are expected to participate in the recruitment and treatment of study patients.
Co-Principal Investigator Prof. Wakili praised the excellent collaboration among all those involved: “CABA-MiTRA-AFNET12-DZHK34 is a team effort. Thanks to the tireless dedication of AFNET and the participating study centers, as well as the fruitful cooperation with the DZHK and our other partners, we have been able to successfully launch the study and enroll our first patient.”
Atrial fibrillation and mitral regurgitation often occur together
Current data suggest that the complication-preventing effect of early atrial fibrillation ablation is due to a reduction in atrial fibrillation burden. To investigate this relationship, atrial fibrillation burden is also being quantitatively assessed as part of a substudy. To this end, participants at some study sites are being offered the option of having an event recorder implanted, which allows for the precise measurement of atrial fibrillation burden.
“Atrial fibrillation and mitral valve regurgitation frequently occur together in older adults. Not only are these two conditions linked by a complex pathophysiological interaction, but their prevalence is also expected to increase due to the aging population and other factors, such as obesity. Optimal treatment for this patient group is therefore becoming increasingly important,” explains co-principal investigator Prof. Steven.
Co-principal investigator Prof. Eckardt summarizes: “The results of the CABA-MiTRA-AFNET12-DZHK34 study have the potential to improve treatment for people with atrial fibrillation and mitral valve regurgitation. Our study thus has the potential to contribute to healthier aging in this population group, which is at increased risk for premature death, stroke, and heart failure.”
CABA-MiTRA-AFNET12-DZHK34 is an investigator-initiated trial run by DZHK and the Atrial Fibrillation Competence Network (AFNET). It compares two approved treatment strategies for patients with atrial fibrillation. DZHK is providing financial support for the study and is involved as a cooperation partner. The trial sponsor is AFNET. Additional funding has been provided by the German Heart Foundation (Deutsche Herzstiftung), as well as by Abbott Medical, Boston Scientific and Biosense Webster/Johnson & Johnson.
Source: AFNET press release
Study title:
Catheter Ablation for Atrial Fibrillation in Patients with Severe Mitral Regurgitation after Successful Transcatheter Mitral-Valve Repair
NCT07380932
Atrial Fibrillation Competence Network:
www.kompetenznetz-vorhofflimmern.de
Press contact:
Dr. Angelika Leute, Tel: 0202 2623395, a.leute@t-online.de
