Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in Cardiac Resynchronisation Therapy (CRT) Patients
Efface
1 other identifier
observational
132
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2008
Typical duration for all trials
10 active sites
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
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 19, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFebruary 4, 2019
February 1, 2019
1.5 years
November 17, 2010
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of patients with at least one acceptable LV pacing configuration.
Amount of patients with at least one acceptable, programmable LV pacing configuration. Definition of acceptable LV pacing configuration: LV pacing threshold \<=2.5V@0.5ms AND Phrenic nerve threshold is at least twice as high as LV pacing threshold AND LV pacing impedance \>=200 Ohms. Only patients with implanted CRT-D and bipolar leftventricular lead are taken into account.
First Follow Up after hospital discharge (approx. 1-3 months)
Eligibility Criteria
Patients with indication for implantation of CRT-D device
You may qualify if:
- indication for CRT-D implantation / upgrade
- written informed consent
You may not qualify if:
- pregnancy
- age \< 18 years
- patients, who cannot visit the routine follow ups (within first 3.5months)
- participants to other studies with active treatment arm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Medizinische Einrichtungen der RWTH Aachen
Aachen, 52074, Germany
Hufeland Klinikum GmbH
Bad Langensalza, 99947, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, 60389, Germany
Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen
Giessen, 35392, Germany
Universitäres Herzzentrum Hamburg GmbH (UHZ)
Hamburg, 20246, Germany
Katholisches Krankenhaus Marienhospital Universitätsklinik
Herne, 44625, Germany
Klinikum Kassel gGmbH
Kassel, 34125, Germany
Universitätsklinikum Leipzig AÖR
Leipzig, 04103, Germany
Niels-Stensen-Kliniken Marienhospital
Osnabrück, 49074, Germany
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, 06484, Germany
Related Publications (1)
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.
PMID: 22277645RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norbert Klein, Dr. med.
Universitätsklinikum Leipzig AÖR
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 19, 2010
Study Start
March 1, 2008
Primary Completion
September 1, 2009
Study Completion
August 1, 2011
Last Updated
February 4, 2019
Record last verified: 2019-02