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

Medtronic

Status: Terminated

Conditions: Atrial Fibrillation

Treatments: Device: Holter Recording_ NEMon DR220 Holter Recorders; Device: Spinal Cord Stimulation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02530203

SCS-PAF

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Conventional treatment

Other group

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.

Treatment:

Device: Holter Recording_ NEMon DR220 Holter Recorders

Spinal Cord Stimulation System

Experimental group

Description:

This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.

Treatment:

Device: Spinal Cord Stimulation System

Device: Holter Recording_ NEMon DR220 Holter Recorders