Trials / Terminated
TerminatedNCT02530203
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Medtronic BRC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Spinal Cord Stimulation System | High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart |
| DEVICE | Holter Recording_ NEMon DR220 Holter Recorders | 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. |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2015-08-20
- Last updated
- 2016-04-06
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02530203. Inclusion in this directory is not an endorsement.