Atrial Fibrillation Clinical Trial
Official title:
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
Patients will be randomized to control and spinal cord stimulation arm (SCS) to investigate the effect of SCS on the occurrence of post-operative atrial fibrillation in the five days after surgery.
Pre market single center clinical research feasibility study. Non blinded randomized
controlled study. 52 patients undergoing CABG procedure will be enrolled and randomized into
two different group (26 person each): the Spinal Cord Stimulation (SCS) and the control
group. The first group will be implanted before the CABG procedure with a temporary SCS lead
(5 days) while the second one will not. The lead will be connected to an external
stimulator.
The day of the CABG surgery, before the scheduled procedure, the patients in the treatment
group will be implanted with the SCS lead. CABG procedure follows the SCS lead implantation.
SCS will be switched off before surgery.
After the CABG procedure, all patients will be hospitalized for minimally five days at the
end of which they will be discharged. The Primary Endpoint data will be collected from the
day of CABG procedure (Day-0) until Day-5. SCS lead will be removed on Day-5.
1-week follow up visit will be performed one week after discharge. End-points will be
evaluated at various time before, during and after surgery. In both groups arrhythmic
episodes for primary and secondary endpoints will be recorded via a Holter monitor
(recording 5 days continuously).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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