Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

Not Applicable

• Conditions: Surgical Clip; Intracranial Aneurysm
• Interventions: Procedure: Rapid Ventricular Pacing

• Registration Number: NCT02766972
• Lead Sponsor: University Clinic Frankfurt

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-04-29
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-10
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26
• Primary Completion: 2020-12
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RVP	Rapid Ventricular Pacing	-

Primary Outcome Measures

Name	Time	Method
modified Rankin scale	6 months

Secondary Outcome Measures

Name	Time	Method
safety of pacing catheter	intraoperatively upt o 24 hours after operation	Complications during insertion, positioning, application (intraoperatively) and removal of pacing catheter (postoperatively on ICU). Anesthesiologist has to complete a questionnaire.
Cardiovascular events	intraoperatively upt o 24 hours after operation	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.
Efficacy of flow reduction and improvement of clip application	intraoperatively	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.
occlusion rate of aneurysm	1 week after operation	Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping.

Trial Locations

Locations (1)

Goethe University Hospital; 🇩🇪 Frankfurt/Main, Germany