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Spinal Cord Stimulation to treat post-operative AF

Spinal Cord Stimulation to treat post-operative AF - SCS-PAF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41184
Enrollment
50
Registered
2014-10-21
Start date
2015-03-12
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-operative atrial fibrillation

Interventions

Half (n=25) of the patients will receive a temporary lead into the spinal cord and will receive spinal carod stimulation(SCS) for 5 days after the CABG procedure. Conform the standard procedures for

Sponsors

Medtronic Trading NL BV
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients which will be subjected to an OFF-pump CABG procedure

Exclusion criteria

Exclusion criteria: 1) Patients with known history of atrial arrhythmias. 2) Patients which are not treated with *-blockers unless heart rate is too low for B-blockers assumption.

Design outcomes

Primary

MeasureTime frame
See protocol page 19. The primary objective is to determine the occurrence of post-operative AT/AF between the start of anesthesia and 5 days after CABG surgery in randomized groups, defined as patients in the control group and patient receiving SCS.

Secondary

MeasureTime frame
See protocol page 19, 20. - Description of integral medication related to AT/AF and pain - Description of number of cardioversion - Description of hospitalizations longer than 5 days - Description of blood pressure and heart rate - Description of the total number of AT/AF episodes - Description of the burden of AT/AF episodes - Description of the amount of premature atrial beats - Description of the total number of VT/VF episodes - Description of the burden of VT/VF episodes - Improvement LF/HF ratio of Heart Rate Variability - Description of pain-score - Description of blader function

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)