An observational study in Cardiac Pacing, Artificial, Aneurysm, Brain and Arteriovenous Malformations, Cerebral, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by University Hospital, Antwerp · Observational
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Among 15 studies in Intracranial Aneurysm with a site in Belgium — 4 open to participants now, 7 under way, none of them phase 3. Intracranial Aneurysm · Belgium.
Among the 15 studies in Intracranial Aneurysm with a site in Belgium, this one is the 12th largest by enrollment of the 12 observational ones that give a count, is the only one that started in 2011, is one of 12 observational ones, and was the 9th registered.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
Browse Intracranial Aneurysm studies →4 of the 15 studies in Intracranial Aneurysm with a site in Belgium are open now. Recruiting first, the newest first:
University Hospital, Ghent · Sites in Belgium
Erasme University Hospital · Sites in Belgium
Ages 18–100
Medtronic Neurovascular Clinical Affairs · Sites in Belgium, Argentina, Australia and 21 more countries
Ages 18+
Medtronic · Sites in Belgium, United States, Argentina and 38 more countries
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2011.
This study's enrollment of 27 is below the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Median enrollment 59 across the 3 interventional studies, 220 across the 12 observational. Of the 8 that completed or were terminated, 1 (13%) have results posted.
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8 of 15 have an industry lead sponsor. The 10 most frequent:
University Hospital, Antwerp is the lead sponsor of 243 studies on the registry; 66 are open to participants now.
University Hospital, Antwerp has 3 studies filed under Intracranial Aneurysm — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Intracranial Aneurysm with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both markers for ischemia damage.
Patients older than 18 years, schedulled for elective brain surgery and not responding to any of the exclusion criteria
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During surgery patients allocated to this group will undergo RVP. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.
Procedure: Rapid ventricular pacing (RVP)
No rapid ventricular pacing is applied during surgery. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.
Procedure: No rapid ventricular pacing
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.
Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline)
For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively
Time frame: A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 24 hours up to 60 hours after start surgery
Magnetic resonance imaging or computed tomography
Magnetic resonance imaging or computed tomography of the brain pre-and postoperatively is used as standard of care. To screen for RVP induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on)and fossa posterior will be evaluated.
Time frame: Preoperative and within 1 week post surgery
Ran from Aug 2011 to primary completion in Jan 2013, 16 months.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp →