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- Klinische Studie NCT02530203
Spinal Cord Stimulation to Treat Post-operative Atrial Fibrillation (SCS-PAF)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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).
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Enschede, Niederlande, 7511 JX
- Medisch Spectrum Twente (MST)
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: 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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Atrial fibrillation
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Medication
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jan Diephuis, PhD, Medisch Spectrum Twente
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SCS-PAF
Plan für individuelle Teilnehmerdaten (IPD)
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