NCT02530203

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

May 11, 2015

Last Update Submit

April 5, 2016

Conditions

Atrial Fibrillation

Keywords

post-operative atrial fibrillationspinal cord stimulationCABG

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation

    AT/AF will be defined as an episode with an atrial rate \>175 bpm lasting ≥ 20 seconds.

    5 days after CABG

Secondary Outcomes (13)

  • Medication

    5 days after CABG

  • Cardioversion

    5 days after CABG

  • Hospitalizations Days

    1 week after discharge

  • BP

    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.

    5 days after CABG

  • +8 more secondary outcomes

Study Arms (2)

Conventional treatment

OTHER

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

Spinal Cord Stimulation System

EXPERIMENTAL

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

Device: Spinal Cord Stimulation SystemDevice: Holter Recording_ NEMon DR220 Holter Recorders

Interventions

Spinal Cord Stimulation SystemDEVICE

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)
Spinal Cord Stimulation System
Holter Recording_ NEMon DR220 Holter RecordersDEVICE

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.

Conventional treatmentSpinal Cord Stimulation System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medisch Spectrum Twente (MST)

Enschede, 7511 JX, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jan Diephuis, PhD

    Medisch Spectrum Twente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

August 20, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

NL(1)