Clinical trial NCT02530203: Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
Official title: Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: post-operative atrial fibrillation
spinal cord stimulation
CABG
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation
timeFrame: 5 days after CABG
Secondary outcomes:
measure: Medication
timeFrame: 5 days after CABG
measure: Cardioversion
timeFrame: 5 days after CABG
measure: Hospitalizations Days
timeFrame: 1 week after discharge
measure: BP
timeFrame: 5 days after CABG
measure: 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.
timeFrame: 5 days after CABG
measure: Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
timeFrame: 5 days after CABG
measure: Premature atrial beats
timeFrame: 5 days after CABG
measure: VT/VF episodes
timeFrame: 5 days after CABG
measure: Burden VT/VF episodes
timeFrame: 5 days after CABG
measure: HRV
timeFrame: 5 days after CABG
measure: Pain on the VAS scale
timeFrame: 5 days after CABG
measure: Bladder function
timeFrame: 5 days after CABG
measure: HR
timeFrame: 5 days after CABG
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente (MST)
Study officials:
affiliation: Medisch Spectrum Twente
name: Jan Diephuis, PhD
role: PRINCIPAL_INVESTIGATOR
References: