Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients

NCT ID: NCT01244308

Last Updated: 2019-02-04

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

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-08-31

Brief Summary

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It's the aim of this study to analyse efficacy and reliability of VectSelect Feature for avoidance of phrenic nerve stimulation in cardiac resynchronisation therapy (CRT) patients.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* indication for CRT-D implantation / upgrade
* written informed consent

Exclusion Criteria

* pregnancy
* age \< 18 years
* patients, who cannot visit the routine follow ups (within first 3.5months)
* participants to other studies with active treatment arm
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norbert Klein, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Leipzig AÖR

Locations

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Medizinische Einrichtungen der RWTH Aachen

Aachen, , Germany

Site Status

Hufeland Klinikum GmbH

Bad Langensalza, , Germany

Site Status

Cardioangiologisches Centrum Bethanien

Frankfurt am Main, , Germany

Site Status

Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen

Giessen, , Germany

Site Status

Universitäres Herzzentrum Hamburg GmbH (UHZ)

Hamburg, , Germany

Site Status

Katholisches Krankenhaus Marienhospital Universitätsklinik

Herne, , Germany

Site Status

Klinikum Kassel gGmbH

Kassel, , Germany

Site Status

Universitätsklinikum Leipzig AÖR

Leipzig, , Germany

Site Status

Niels-Stensen-Kliniken Marienhospital

Osnabrück, , Germany

Site Status

Klinikum Dorothea Christiane Erxleben GmbH

Quedlinburg, , Germany

Site Status

Countries

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Germany

References

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Klein N, Klein M, Weglage H, Przibille O, Fischer S, Trappe HJ, Birkenhauer F, Pfeiffer D; Efface Phrenic Stim Study Group. Clinical efficacy of left ventricular pacing vector programmability in cardiac resynchronization therapy defibrillator patients for management of phrenic nerve stimulation and/or elevated left ventricular pacing thresholds: insights from the Efface Phrenic Stim study. Europace. 2012 Jun;14(6):826-32. doi: 10.1093/europace/eur412. Epub 2012 Jan 25.

Reference Type RESULT
PMID: 22277645 (View on PubMed)

Other Identifiers

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T86

Identifier Type: -

Identifier Source: org_study_id

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