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Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study.
Treatment of complex unruptured intracranial aneurysms (UIA) remains challenging to date. Therefore, advanced techniques are required to achieve an optimal result in treating these patients safely. In this study, the safety and efficacy of rapid ventricular pacing (RVP) to facilitate microsurgical clip-reconstruction has been studied prospectively in a joined neurosurgical, anesthesiological and cardiological study. Patients with complex UIA were prospectively enrolled and the safety and efficacy of RVP were evaluated recording cardiovascular events and outcome of the patients as well as the amount of aneurysm occlusion after the surgical clip-reconstruction procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RVP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Ventricular Pacing | Procedure | Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin scale | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of flow reduction and improvement of clip application | Efficacy of flow reduction (failure rate of pacing; measuring of heart rate and blood pressure). Also improvement of clip application: performing surgeon has to complete a questionnaire. | intraoperatively |
| safety of pacing catheter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Sicking | Contact | 0696301 | 4291 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goethe University Hospital | Recruiting | Frankfurt am Main | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28820303 | Derived | Konczalla J, Platz J, Fichtlscherer S, Mutlak H, Strouhal U, Seifert V. Rapid ventricular pacing for clip reconstruction of complex unruptured intracranial aneurysms: results of an interdisciplinary prospective trial. J Neurosurg. 2018 Jun;128(6):1741-1752. doi: 10.3171/2016.11.JNS161420. Epub 2017 Aug 18. |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Complications during insertion, positioning, application (intraoperatively) and removal of pacing catheter (postoperatively on ICU). Anesthesiologist has to complete a questionnaire. |
| intraoperatively upt o 24 hours after operation |
| Cardiovascular events | All cardiovascular events will be documented (like arrhythmias etc.). Also preoperative heart values (of Troponin T, CK, CK-MB) and values after operation and one day after operation will be documented and afterwards analyzed. Reference values (05/2016): CK <190 U/l; CK-MB <24 U/l; Troponin T <14pg/ml Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment were documented and analyzed. | intraoperatively upt o 24 hours after operation |
| occlusion rate of aneurysm | Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping. | 1 week after operation |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |