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

5. april 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Enschede, Holland, 7511 JX
        • Medisch Spectrum Twente (MST)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Enhed: 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.
Eksperimentel: Spinal Cord Stimulation System
This group will receive the Spinal Cord Stimulation System and they will wear the Holter for 5 days.
Enhed: 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.
Enhed: Spinal Cord Stimulation System
High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
Andre navne:
  • (Medtronic External Neurostimulator Model 37022; Medtronic 1x8 Standard LZ Lead Model 3877; Medtronic MultiLead Trialing Cable MLTC Model 355531)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Atrial fibrillation
Tidsramme: 5 days after CABG
AT/AF will be defined as an episode with an atrial rate >175 bpm lasting ≥ 20 seconds.
5 days after CABG

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication
Tidsramme: 5 days after CABG
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.
5 days after CABG
Cardioversion
Tidsramme: 5 days after CABG
Description of number of cardioversion needed in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
5 days after CABG
Hospitalizations Days
Tidsramme: 1 week after discharge
Description of hospitalizations longer than 5 days as required by the protocol and clinical practice in the treatment (SCS) and control group.
1 week after discharge
BP
Tidsramme: 5 days after CABG
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.
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.
Tidsramme: 5 days after CABG
AT/AF episodes
5 days after CABG
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
AT/AF burden
5 days after CABG
Premature atrial beats
Tidsramme: 5 days after CABG
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.
5 days after CABG
VT/VF episodes
Tidsramme: 5 days after CABG
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.
5 days after CABG
Burden VT/VF episodes
Tidsramme: 5 days after CABG
Description of the burden of VT/VF episodes in the treatment (SCS) and control group between start of anesthesia and 5 days after surgery.
5 days after CABG
HRV
Tidsramme: 5 days after CABG
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.
5 days after CABG
Pain on the VAS scale
Tidsramme: 5 days after CABG
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.
5 days after CABG
Bladder function
Tidsramme: 5 days after CABG
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.
5 days after CABG
HR
Tidsramme: 5 days after CABG
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.
5 days after CABG

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medtronic BRC

Efterforskere

  • Ledende efterforsker: Jan Diephuis, PhD, Medisch Spectrum Twente

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2015

Primær færdiggørelse (Faktiske)

1. februar 2016

Studieafslutning (Faktiske)

1. februar 2016

Datoer for studieregistrering

Først indsendt

11. maj 2015

Først indsendt, der opfyldte QC-kriterier

19. august 2015

Først opslået (Skøn)

20. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SCS-PAF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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