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Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With Quadripolar Left Ventricular Leads (EffaceQ)

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: November 30, 2011
Last updated: November 21, 2014
Last verified: November 2014

Cardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads.

Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.

Condition Intervention
Heart Failure Device: quadripolar LV lead (Quartet)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads

Resource links provided by NLM:

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percentage of patients with at least one acceptable lead vector [ Time Frame: Pre hospital discharge (PHD) to 3 months ]

    Definition of acceptable lead vector:

    Any LV vector that complies in both tested body positions with both criteria:

    1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
    2. LV pacing threshold is less or equals 2.5V@0.5ms

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline to 3 months ]
    Minnesota living with heart failure questionaire

  • Phrenic nerve stimulation (PNS) [ Time Frame: PHD to 3 months ]
    • Incidence of PNS per LV pacing vector
    • Freedom from PNS for the permanently programmed LV vector

  • LV pacing thresholds [ Time Frame: PHD to 3 months ]
    • LV pacing thresholds per LV vector
    • Incidence of elevated (>2.5V/0.5ms) LV pacing thresholds per LV vector

  • Number of acceptable LV lead vectors per patient [ Time Frame: PHD to 3 months ]
  • Finally programmed LV lead vector [ Time Frame: PHD to 3 months ]
    • Need for reprogramming
    • Percentage of patients with conventional (bipolar) and extended (quadripolar) LV vectors

Enrollment: 337
Study Start Date: November 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Quadripolar lead
All participants receive a CRT-D system with quadripolar lead
Device: quadripolar LV lead (Quartet)
All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
Other Name: Quartet

Detailed Description:

Definition of an acceptable lead vector: Any LV pacing vector that complies in both tested body positions (left lateral position and sitting) with both criteria:

  1. Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
  2. LV pacing threshold is less or equals 2.5Volts (V) @0.5 milliseconds (ms)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are planned for being implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (CRT-D) system in the participating centers.

Inclusion Criteria:

  • Indication for implantation of a CRT-D
  • Age >= 18 years
  • Written informed consent

Exclusion Criteria:

  • Already implanted LV or coronary sinus lead
  • Previous unsuccessful LV lead implant attempt
  • Patient is eligible for heart transplantation
  • Comorbidities that results in life expectancy of less than 12 months
  • Known pregnancy
  • Inability to provide written patient informed consent
  • Participation to another study with active treatment arm (i.e. randomized studies etc...)
  • Patient is not willing or is not able to visit the study center for the study assessments within the first 3 months after implant
  • Patient is not able to understand or answer the quality of life questionaire
  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 identifier: NCT01484613

Klinikum Coburg GmbH
Coburg, Germany, 96450
Krankenhaus Mörsenbroich-Rath GmbH
Düsseldorf, Germany, 40472
Klinikum Esslingen
Esslingen, Germany, 73730
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Germany, 60389
Universitätsklinik Freiburg
Freiburg, Germany, 79106
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
Göttingen, Germany, 37073
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Evangelisches Krankenhaus Kalk
Köln, Germany, 51103
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, Germany, 67063
St.-Marien-Hospital GmbH
Lünen, Germany, 44534
Klinikum Magdeburg gGmbH
Magdeburg, Germany, 39130
Marl, Germany, 45768
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, Germany, 81377
Universitätsklinikum Münster
Münster, Germany, 48149
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, Germany, 49074
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, Germany, 06484
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Johannes Brachmann, Prof. Klinikum Coburg GmbH
  More Information

Responsible Party: St. Jude Medical Identifier: NCT01484613     History of Changes
Other Study ID Numbers: H56
Study First Received: November 30, 2011
Last Updated: November 21, 2014

Keywords provided by St. Jude Medical:
Hear Failure
Cardiac resynchronization

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
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Physiological Effects of Drugs processed this record on September 21, 2017