Randomized Efficacy Study of Surgical Treatment for Irregular Heartbeat = Atrial Fibrillation (Randomization = treatment assigned randomly)
Summary description of the study
The study focuses on the surgical treatment (ablation) of atrial fibrillation. Atrial fibrillation is one of the most common heart rhythm disorders, where the heart beats irregularly and often too quickly. Untreated atrial fibrillation can lead to severe heart failure in the long term, which impacts quality of life. Surgical elimination of atrial fibrillation during heart surgery may reduce the risk of heart failure.
(BASEC)
Intervention under investigation
During ablation, the faulty electrical signals causing atrial fibrillation are interrupted by creating barriers/scars on the affected heart tissue. This aims to restore the normal or regular heart rhythm. This procedure takes about 10 minutes. The success rate of this treatment is about 60-70%.
(BASEC)
Disease under investigation
irregular heartbeat, atrial fibrillation
(BASEC)
Age 18 years and older Must undergo a cardiac surgical procedure, including coronary artery bypass surgery, aortic valve replacement, or combinations thereof. They suffer from atrial fibrillation They have consented to participate in the study (BASEC)
Exclusion criteria
Persistent atrial fibrillation (absence of any sinus rhythm for more than one year) Previous heart surgeries that required opening the pericardium Patients undergoing any of the following procedures: A. Heart transplantation B. Complex procedures for congenital heart defects C. The sole indication for surgery is the placement of a heart support system D. Repair or replacement of the mitral valve E. Repair or replacement of the tricuspid valve F. Closure of an atrial septal defect (excluding PFOs) or a ventricular septal defect (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
There is no CRO in this project
(BASEC)
Contact
Contact Person Switzerland
Prof Dr. med. Florian Schönhoff
+41 31 632 5000
florian.schoenhoff@clutterinsel.chUniversitätsklinik für Herzchirurgie, Inselspital Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
21.05.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Surgical Ablation of Atrial Fibrillation Efficacy (SAFE) trial (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available