An interventional study of Spinal Cord Stimulation System and Holter Recording_ NEMon DR220 Holter Recorders in Atrial Fibrillation, sponsored by Medtronic BRC. Terminated at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Medtronic BRC · Not applicable, Interventional, and Treatment
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).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 4 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Medtronic BRC is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
Non interventional group, patients that belong to this arm will receive the conventional treatment for CABG and they will wear the Holter for 5 days.
Device: Holter Recording_ NEMon DR220 Holter Recorders
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
Device: Spinal Cord Stimulation System · Device: Holter Recording_ NEMon DR220 Holter Recorders
High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
Also known as: (Medtronic External Neurostimulator Model 37022; Medtronic 1x8 Standard LZ Lead Model 3877; Medtronic MultiLead Trialing Cable MLTC Model 355531)
To measure primary endpoint and most of the secondary endpoints in all the patients enrolled in the study. The recording will start to before CABG procedure and will be stop at day 5.
Atrial fibrillation
AT/AF will be defined as an episode with an atrial rate \>175 bpm lasting ≥ 20 seconds.
Time frame: 5 days after CABG
Medication
Description of integral medication related to AT/AF occurrence and pain in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Time frame: 5 days after CABG
Cardioversion
Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Time frame: 5 days after CABG
Hospitalizations Days
Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
Time frame: 1 week after discharge
BP
Description of 1) intra arterial blood pressure as averaged over the first 24 hours after surgery and 2) arterial blood pressure as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
Time frame: 5 days after CABG
Description of the total number of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
AT/AF episodes
Time frame: 5 days after CABG
Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
AT/AF burden
Time frame: 5 days after CABG
Premature atrial beats
Description of the amount of premature atrial beats in the treatment (SCS) and control group from the end of the procedure till Day-5 after surgery.
Time frame: 5 days after CABG
VT/VF episodes
Description of the total number of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Time frame: 5 days after CABG
Burden VT/VF episodes
Description of the burden of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Time frame: 5 days after CABG
HRV
Improvement LF/HF ratio of Heart Rate Variability (HRV) by SCS. SCS On and Off will be compared in each patients in the treatment (SCS) group before surgery and 5 days after surgery.
Time frame: 5 days after CABG
Pain on the VAS scale
Description of pain-score due to CABG surgery measured with a VAS score three times a from Day-1 till Day-5 after surgery in the treatment (SCS) and control group.
Time frame: 5 days after CABG
Bladder function
The extra time the bladder catheter will be kept in the patients after the first 2 days after surgery will be described in the treatment (SCS) and control group in order to assess bladder function.
Time frame: 5 days after CABG
HR
Description of 1) heart rate as averaged over the first 24 hours after surgery and 2) heart rate as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
Time frame: 5 days after CABG
Plan to share: Undecided
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