Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

Official title:

Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02766972
• Other study ID #: 497/13
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2016
• Last updated: October 25, 2017
• Start date: July 2013
• Est. completion date: June 2021

Study information

• Verified date: October 2017
• Source: University Clinic Frankfurt
• Contact: Anne Sicking
• Phone: 0696301
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Surgical Clip

Intervention

Procedure:
• Rapid Ventricular Pacing
Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms

Locations

Country	Name	City	State
Germany	Goethe University Hospital	Frankfurt/Main

Sponsors (1)

Lead Sponsor	Collaborator
University Clinic Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin scale		6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	occlusion rate of aneurysm	Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping.	1 week after operation