Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

October 25, 2017 updated by: Juergen Konczalla, University Clinic Frankfurt
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt/Main, Germany
        • Recruiting
        • Goethe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RVP
Procedure: Rapid Ventricular Pacing
Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
modified Rankin scale
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of flow reduction and improvement of clip application
Time Frame: 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.
intraoperatively
safety of pacing catheter
Time Frame: 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.
intraoperatively upt o 24 hours after operation
Cardiovascular events
Time Frame: 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.
intraoperatively upt o 24 hours after operation
occlusion rate of aneurysm
Time Frame: 1 week after operation
Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping.
1 week after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Clinic Frankfurt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 497/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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