Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation (SCS-PAF)
5. april 2016 oppdatert av: Medtronic BRC
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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Intervensjonell
Registrering (Faktiske)
4
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Enschede, Nederland, 7511 JX
- Medisch Spectrum Twente (MST)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
- Ablation procedure
- Cardiac surgery
- 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)
- Patients already implanted with cardiac devices
- Patients with existing implanted neurostimulators
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Conventional treatment
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.
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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.
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Eksperimentell: Spinal Cord Stimulation System
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
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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.
High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Atrial fibrillation
Tidsramme: 5 days after CABG
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AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
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5 days after CABG
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medication
Tidsramme: 5 days after CABG
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Description of integral medication related to AT/AF occurrence and pain in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
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Cardioversion
Tidsramme: 5 days after CABG
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Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
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Hospitalizations Days
Tidsramme: 1 week after discharge
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Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
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1 week after discharge
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BP
Tidsramme: 5 days after CABG
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Description of 1) intra arterial blood pressure as averaged over the first 24 hours after surgery and 2) arterial blood pressure as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
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5 days after CABG
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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.
Tidsramme: 5 days after CABG
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AT/AF episodes
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5 days after CABG
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Description of burden of AT/AF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
Tidsramme: 5 days after CABG
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AT/AF burden
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5 days after CABG
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Premature atrial beats
Tidsramme: 5 days after CABG
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Description of the amount of premature atrial beats in the treatment (SCS) and control group from the end of the procedure till Day-5 after surgery.
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5 days after CABG
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VT/VF episodes
Tidsramme: 5 days after CABG
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Description of the total number of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
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Burden VT/VF episodes
Tidsramme: 5 days after CABG
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Description of the burden of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
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5 days after CABG
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HRV
Tidsramme: 5 days after CABG
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Improvement LF/HF ratio of Heart Rate Variability (HRV) by SCS.
SCS On and Off will be compared in each patients in the treatment (SCS) group before surgery and 5 days after surgery.
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5 days after CABG
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Pain on the VAS scale
Tidsramme: 5 days after CABG
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Description of pain-score due to CABG surgery measured with a VAS score three times a from Day-1 till Day-5 after surgery in the treatment (SCS) and control group.
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5 days after CABG
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Bladder function
Tidsramme: 5 days after CABG
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The extra time the bladder catheter will be kept in the patients after the first 2 days after surgery will be described in the treatment (SCS) and control group in order to assess bladder function.
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5 days after CABG
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HR
Tidsramme: 5 days after CABG
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Description of 1) heart rate as averaged over the first 24 hours after surgery and 2) heart rate as determined using a blood pressure cuff at a specific time on Day-2, Day-3, Day-4 and Day-5 after surgery in the treatment (SCS) and control group.
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5 days after CABG
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Jan Diephuis, PhD, Medisch Spectrum Twente
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2015
Primær fullføring (Faktiske)
1. februar 2016
Studiet fullført (Faktiske)
1. februar 2016
Datoer for studieregistrering
Først innsendt
11. mai 2015
Først innsendt som oppfylte QC-kriteriene
19. august 2015
Først lagt ut (Anslag)
20. august 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2016
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SCS-PAF
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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