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Completed

NCT Number: NCT01484613

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Coburg GmbH, Coburg, Germany

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About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

quadripolar LV lead (Quartet)

Device

All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from

Other names: Quartet

Primary outcomes

  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:

    • Phrenic nerve stimulation threshold is at least twice as high as LV pacing threshold
    • LV pacing threshold is less or equals [email protected]

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Effectiveness and Reliability of Selected Site Pacing for Avoidance of Phrenic Nerve Stimulation in CRT Patients With Quadripolar LV Leads

Acronym: EffaceQ

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2011
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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