Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 10:44 PM
Study NCT ID:
NCT03184233
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2017-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Sponsor:
University Hospital, Antwerp
Organization:
Study Overview
Official Title:
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.
Detailed Description:
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 in 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. The investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging, brain oxygenation (Sct O₂) evaluated by near-infrared spectroscopy 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, Sct O2 (3) and troponin levels (4) both markers for ischemia damage.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: