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Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

Primary Purpose

Intracranial Aneurysm, Surgical Clip

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rapid Ventricular Pacing
Sponsored by
University Clinic Frankfurt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm, Surgical Clipping, Rapid Ventricular Pacing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Goethe University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RVP

Arm Description

Outcomes

Primary Outcome Measures

modified Rankin scale

Secondary Outcome Measures

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.
safety of pacing catheter
Complications during insertion, positioning, application (intraoperatively) and removal of pacing catheter (postoperatively on ICU). Anesthesiologist has to complete a questionnaire.
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.
occlusion rate of aneurysm
Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping.

Full Information

First Posted
April 29, 2016
Last Updated
October 25, 2017
Sponsor
University Clinic Frankfurt
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1. Study Identification

Unique Protocol Identification Number
NCT02766972
Brief Title
Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
Official Title
Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Clinic Frankfurt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Surgical Clip
Keywords
Intracranial Aneurysm, Surgical Clipping, Rapid Ventricular Pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RVP
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rapid Ventricular Pacing
Intervention Description
Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms
Primary Outcome Measure Information:
Title
modified Rankin scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy of flow reduction and improvement of clip application
Description
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.
Time Frame
intraoperatively
Title
safety of pacing catheter
Description
Complications during insertion, positioning, application (intraoperatively) and removal of pacing catheter (postoperatively on ICU). Anesthesiologist has to complete a questionnaire.
Time Frame
intraoperatively upt o 24 hours after operation
Title
Cardiovascular events
Description
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.
Time Frame
intraoperatively upt o 24 hours after operation
Title
occlusion rate of aneurysm
Description
Angiography to control the occlusion of the aneurysm, regularly 1 week after surgical clipping.
Time Frame
1 week after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Sicking
Phone
0696301
Ext
4291
Facility Information:
Facility Name
Goethe University Hospital
City
Frankfurt/Main
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Sicking
First Name & Middle Initial & Last Name & Degree
Juergen Konczalla, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28820303
Citation
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.
Results Reference
derived

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Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

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