Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation (SCS-PAF)

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.

Study Overview

• Status: Terminated
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Holter Recording_ NEMon DR220 Holter Recorders; Device: Spinal Cord Stimulation System

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Enschede, Netherlands, 7511 JX
    • Medisch Spectrum Twente (MST)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients which will be subjected to an OFF-pump CABG procedure
2. More than 18 years of age
3. Subject is able and willing to give informed consent.

Exclusion Criteria:

1. Patients with known history of atrial arrhythmias.
2. Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
3. Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
4. Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
5. Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
6. Hypotension (RR systolic <100 or RR diastolic <50).
7. Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
8. Subject is diagnosed with epilepsy or history of seizures.
9. Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
10. Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
11. Patients with long QT syndrome.
12. Patients with Brugada syndrome.
13. Patients affected by Polyneuropathy (e.g. due to diabetes).
14. Patients affected by pericarditis

15. Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:

    • Ablation procedure
    • Cardiac surgery
16. Pregnant patients or nursing (subjects who are of child bearing potential and are not on a reliable form of birth control will undergo a pregnancy test)
17. Patients already implanted with cardiac devices
18. Patients with existing implanted neurostimulators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional treatment; 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; 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.
Experimental: Spinal Cord Stimulation System; This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.	Device: Holter Recording_ NEMon DR220 Holter Recorders; 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.; Device: Spinal Cord Stimulation System; High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart; Other Names: (Medtronic External Neurostimulator Model 37022; Medtronic 1x8 Standard LZ Lead Model 3877; Medtronic MultiLead Trialing Cable MLTC Model 355531)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation	AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.	5 days after CABG

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	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	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.	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.	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.	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.	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.	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.	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.	5 days after CABG

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: Jan Diephuis, PhD, Medisch Spectrum Twente

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 20, 2015

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: CABG; spinal cord stimulation; post-operative atrial fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SCS-PAF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED