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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484613
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : November 24, 2014
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:

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 or disease Intervention/treatment
Heart Failure Device: quadripolar LV lead (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)

Study Type : Observational
Actual Enrollment : 337 participants
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
Study Start Date : November 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Quality of Life [ Time Frame: Baseline to 3 months ]
    Minnesota living with heart failure questionaire

  2. 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

  3. 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

  4. Number of acceptable LV lead vectors per patient [ Time Frame: PHD to 3 months ]
  5. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: St. Jude Medical Identifier: NCT01484613     History of Changes
Other Study ID Numbers: H56
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: November 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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