Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation (SCS-PAF)
5 de abril de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Actual)
4
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Enschede, Países Bajos, 7511 JX
- Medisch Spectrum Twente (MST)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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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Experimental: 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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Atrial fibrillation
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Medication
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jan Diephuis, PhD, Medisch Spectrum Twente
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2015
Finalización primaria (Actual)
1 de febrero de 2016
Finalización del estudio (Actual)
1 de febrero de 2016
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2015
Primero enviado que cumplió con los criterios de control de calidad
19 de agosto de 2015
Publicado por primera vez (Estimar)
20 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
5 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SCS-PAF
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .