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Rapid Ventricular Pacing in Surgical Treatment of Intracranial Aneurysms

NCT ID: NCT02766972

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Intracranial Aneurysm Surgical Clip

Keywords

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Intracranial Aneurysm Surgical Clipping Rapid Ventricular Pacing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RVP

Group Type EXPERIMENTAL

Rapid Ventricular Pacing

Intervention Type PROCEDURE

Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms

Interventions

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Rapid Ventricular Pacing

Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Clinic Frankfurt

OTHER

Sponsor Role lead

Responsible Party

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Juergen Konczalla

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Goethe University Hospital

Frankfurt am Main, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Anne Sicking

Role: CONTACT

Phone: 0696301

Facility Contacts

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Anne Sicking

Role: primary

References

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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.

Reference Type DERIVED
PMID: 28820303 (View on PubMed)

Other Identifiers

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497/13

Identifier Type: -

Identifier Source: org_study_id