Back to resultsSpinal Cord Stimulation to Treat Post-operative Atrial Fibrillation (SCS-PAF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Spinal Cord Stimulation System
Holter Recording_ NEMon DR220 Holter Recorders
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring post-operative atrial fibrillation, spinal cord stimulation, CABG
Eligibility Criteria
Inclusion Criteria:
- Patients which will be subjected to an OFF-pump CABG procedure
- More than 18 years of age
- Subject is able and willing to give informed consent.
Exclusion Criteria:
- Patients with known history of atrial arrhythmias.
- Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
- Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
- Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
- Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
- Hypotension (RR systolic <100 or RR diastolic <50).
- Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
- Subject is diagnosed with epilepsy or history of seizures.
- Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
- Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
- Patients with long QT syndrome.
- Patients with Brugada syndrome.
- Patients affected by Polyneuropathy (e.g. due to diabetes).
- Patients affected by pericarditis
Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
- Ablation procedure
- Cardiac surgery
- 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)
- Patients already implanted with cardiac devices
- Patients with existing implanted neurostimulators
Sites / Locations
- Medisch Spectrum Twente (MST)
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Conventional treatment
Spinal Cord Stimulation System
Arm Description
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.
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
Outcomes
Primary Outcome Measures
Atrial fibrillation
AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
Secondary Outcome Measures
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.
Cardioversion
Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Hospitalizations Days
Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02530203
Brief Title
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
Acronym
SCS-PAF
Official Title
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Due to a change in medication guidelines it became practically impossible to recruit patients
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
post-operative atrial fibrillation, spinal cord stimulation, CABG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment
Arm Type
Other
Arm Description
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.
Arm Title
Spinal Cord Stimulation System
Arm Type
Experimental
Arm Description
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation System
Other Intervention Name(s)
(Medtronic External Neurostimulator Model 37022; Medtronic 1x8 Standard LZ Lead Model 3877; Medtronic MultiLead Trialing Cable MLTC Model 355531)
Intervention Description
High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
Intervention Type
Device
Intervention Name(s)
Holter Recording_ NEMon DR220 Holter Recorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Atrial fibrillation
Description
AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
Time Frame
5 days after CABG
Secondary Outcome Measure Information:
Title
Medication
Description
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
Title
Cardioversion
Description
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
Title
Hospitalizations Days
Description
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
Title
BP
Description
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
Title
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.
Description
AT/AF episodes
Time Frame
5 days after CABG
Title
Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Description
AT/AF burden
Time Frame
5 days after CABG
Title
Premature atrial beats
Description
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
Title
VT/VF episodes
Description
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
Title
Burden VT/VF episodes
Description
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
Title
HRV
Description
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
Title
Pain on the VAS scale
Description
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
Title
Bladder function
Description
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
Title
HR
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients which will be subjected to an OFF-pump CABG procedure
More than 18 years of age
Subject is able and willing to give informed consent.
Exclusion Criteria:
Patients with known history of atrial arrhythmias.
Patients who are not treated with β-blockers unless heart rate is too low for β-blockers assumption.
Participation in another clinical trial which may affect the outcome within 3 months prior to day of procedure.
Other surgical interventions (e.g. valve replacement) programmed in the same surgical session
Resting pulse rate ≤45 beats / min as assessed before daily doses of β-blockage is administered.
Hypotension (RR systolic <100 or RR diastolic <50).
Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complete bundle branch block.
Subject is diagnosed with epilepsy or history of seizures.
Coagulation abnormalities as determined by anticoagulation guidelines for neuroaxial procedures 2011.
Patients not stabilized on an anti-arrhythmic drug regimen for the last 30 days.
Patients with long QT syndrome.
Patients with Brugada syndrome.
Patients affected by Polyneuropathy (e.g. due to diabetes).
Patients affected by pericarditis
Patients who underwent procedures in the past, which are expected to have changed the innervation of the heart for example:
Ablation procedure
Cardiac surgery
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)
Patients already implanted with cardiac devices
Patients with existing implanted neurostimulators
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Diephuis, PhD
Organizational Affiliation
Medisch Spectrum Twente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch Spectrum Twente (MST)
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
We'll reach out to this number within 24 hrs