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Completed

NCT Number: NCT01295840

Quartet Lead and Resynchronization Therapy Options

The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead.

Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.

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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

Interventional

Phase

Phase 4

Primary location

Hospital Clínico Universitario Virgen de la Victoria

Málaga, 29010, Spain

About this study

This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device.

This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed.

Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
  • Patients who have provided written informed consent
  • Patients who are in sinus rhythm.
  • Patients older than 18 years of age.

Exclusion criteria

  • Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
  • Patients with valvular disease.
  • Patients in functional class New York Heart Association (NYHA) IV
  • Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
  • Patients whose device has been changed/upgraded.
  • Pregnant patients.
  • Patients who do not fulfill all the inclusion criteria.
  • Patients who are unable to provide written informed consent

Treatment and study plan

Cardiac Resynchronization Therapy Defibrillator

Device

Cardiac Resynchronization Therapy Defibrillator

Other names: Promote Q. Model, Promote Quadra™., Quartet®: Tetrapolar left ventricular lead. Model 1458Q.

Primary outcomes

  1. Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.

    Time frame: Enrollment visit (in the seven days after implantation of the device)

Secondary outcomes

  1. Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors

    Time frame: At enrollment

    In patients with best CO obtained from Non-traditional, to calculate the percent difference between the best CO from Non-traditional vectors and best CO from Traditional vectors, vectors.This percentage was the CO from Non-traditional vectors minus CO from Traditional vectors then divided by CO from Traditional vectors.

    The Quartet® lead has 4 poles: Distal (D1), Mid 2 (M2), Mid 3 (M3) and Proximal (P4). The 3 Traditional vectors are the traditional configurations available in a standard bipolar lead: D1-M2, D1-Right Ventricular Coil (RVC) and M2-RVC. The 7 Non-traditional vectors are the additional configurations available in a Quartet® lead: D1-P4, M2-P4, M3-M2, M3-RVC, M3-P4, P4-M2 and P4-RVC.

  2. Cardiac Output (CO) With Different Configurations at Enrollment

    Time frame: Enrollment visit (in the seven days after implantation of the device)

    Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.

  3. Capture Threshold

    Time frame: Enrollment visit (in the seven days after implantation of the device)

    Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

    Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

  4. Capture Threshold

    Time frame: 6 months post-implant

    Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

    Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

  5. Number of Vectors With Phrenic Nerve Stimulation (PNS)

    Time frame: Enrollment visit (in the seven days after implantation of the device)

    Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

    Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, while maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

  6. Number of Vectors With Phrenic Nerve Stimulation (PNS)

    Time frame: At 6 months

    Capture and phrenic threshold data will be recorded for each of the stimulation vectors studied.

    Attempts will also be made to avoid phrenic stimulation in those patients who suffer from it, whilst maintaining good capture thresholds, by changing between the new configurations offered by the Quartet® electrode.

  7. Number of Patients With PNS in All Vectors

    Time frame: At enrollment

    To calculate the number of patients that exhibit PNS in all traditional vector

  8. Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector

    Time frame: At enrollment

    To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector

  9. Number of Patients With PNS in All Vectors

    Time frame: At 6 months

    To calculate the number of patients that exhibit PNS in all traditional vector

  10. Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector

    Time frame: At 6 months

    To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response.

Acronym: QUARTO

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2011
Registry last updated
Feb 20, 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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