Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 29, 2016
CompletedFirst Posted
Study publicly available on registry
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedOctober 26, 2017
October 1, 2017
7.4 years
April 29, 2016
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Rankin scale
6 months
Secondary Outcomes (4)
Efficacy of flow reduction and improvement of clip application
intraoperatively
safety of pacing catheter
intraoperatively upt o 24 hours after operation
Cardiovascular events
intraoperatively upt o 24 hours after operation
occlusion rate of aneurysm
1 week after operation
Study Arms (1)
RVP
EXPERIMENTALInterventions
Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms
Eligibility Criteria
You may qualify if:
- complex UIA intended to be treated by microsurgical clip-reconstruction
- application of RVP intra-operatively
You may not qualify if:
- structural heart disease or conductance abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Goethe University Hospital
Frankfurt am Main, Germany
Related Publications (1)
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.
PMID: 28820303DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 29, 2016
First Posted
May 10, 2016
Study Start
July 1, 2013
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
October 26, 2017
Record last verified: 2017-10