Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

Conditions
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Intracranial Aneurysm, Surgical Clip

Intervention / Treatment
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* Procedure: Rapid Ventricular Pacing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: complex UIA intended to be treated by microsurgical clip-reconstruction application of RVP intra-operatively Exclusion Criteria: structural heart disease or conductance abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RVP<br> | Procedure: Rapid Ventricular Pacing<br>* Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin scale |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial Aneurysm, Surgical Clipping, Rapid Ventricular Pacing