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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01244308
First received: November 17, 2010
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition
Heart Failure

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Reliability of VectSelect™ Feature for Avoidance of Phrenic Nerve Stimulation in CRT Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Amount of patients with at least one acceptable LV pacing configuration. [ Time Frame: First Follow Up after hospital discharge (approx. 1-3 months) ] [ Designated as safety issue: No ]

    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.



Enrollment: 132
Study Start Date: March 2008
Study Completion Date: August 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with indication for implantation of CRT-D device

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244308

Locations
Germany
Medizinische Einrichtungen der RWTH Aachen
Aachen, Germany, 52074
Hufeland Klinikum GmbH
Bad Langensalza, Germany, 99947
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Germany, 60389
Universitätsklinikum Gießen und Marburg GmbH Sitz Gießen
Gießen, Germany, 35392
Universitäres Herzzentrum Hamburg GmbH (UHZ)
Hamburg, Germany, 20246
Katholisches Krankenhaus Marienhospital Universitätsklinik
Herne, Germany, 44625
Klinikum Kassel gGmbH
Kassel, Germany, 34125
Universitätsklinikum Leipzig AÖR
Leipzig, Germany, 04103
Niels-Stensen-Kliniken Marienhospital
Osnabrück, Germany, 49074
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, Germany, 06484
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Norbert Klein, Dr. med. Universitätsklinikum Leipzig AÖR
  More Information

Publications:
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01244308     History of Changes
Other Study ID Numbers: T86
Study First Received: November 17, 2010
Last Updated: July 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
Phrenic nerve stimulation
LV pacing configuration
CRT
Cardiac resynchronisation therapy
Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014