Quartet Lead and Resynchronization Therapy Options (QUARTO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01295840
First received: February 3, 2011
Last updated: March 5, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Heart Failure
Device: Cardiac Resynchronization Therapy Defibrillator
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official 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.

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors [ Time Frame: At enrollment ] [ Designated as safety issue: No ]

    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.


  • Cardiac Output (CO) With Different Configurations at Enrollment [ Time Frame: Enrollment visit (in the seven days after implantation of the device) ] [ Designated as safety issue: No ]
    Means of baseline non-paced CO, best CO obtained from traditional configurations and best CO obtained from all quadripolar configurations at enrollment.

  • Capture Threshold [ Time Frame: Enrollment visit (in the seven days after implantation of the device) ] [ Designated as safety issue: No ]

    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.


  • Capture Threshold [ Time Frame: 6 months post-implant ] [ Designated as safety issue: No ]

    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.


  • Number of Vectors With Phrenic Nerve Stimulation (PNS) [ Time Frame: Enrollment visit (in the seven days after implantation of the device) ] [ Designated as safety issue: No ]

    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.


  • Number of Vectors With Phrenic Nerve Stimulation (PNS) [ Time Frame: At 6 months ] [ Designated as safety issue: No ]

    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.


  • Number of Patients With PNS in All Vectors [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    To calculate the number of patients that exhibit PNS in all traditional vector

  • Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector

  • Number of Patients With PNS in All Vectors [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    To calculate the number of patients that exhibit PNS in all traditional vector

  • Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    To calculate the number of patients, who exhibit PNS in all traditional vector, in which PNS could be avoided using a non-traditional vector


Enrollment: 51
Study Start Date: January 2011
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CRT therapy
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Device: Cardiac Resynchronization Therapy Defibrillator
Cardiac Resynchronization Therapy Defibrillator
Other Names:
  • Promote Q. Model
  • Promote Quadra™.
  • Quartet®: Tetrapolar left ventricular lead. Model 1458Q.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients who have provided written informed consent
  3. Patients who are in sinus rhythm.
  4. Patients older than 18 years of age.

Exclusion Criteria:

  1. Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
  2. Patients with valvular disease.
  3. Patients in functional class New York Heart Association (NYHA) IV
  4. Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
  5. Patients whose device has been changed/upgraded.
  6. Pregnant patients.
  7. Patients who do not fulfill all the inclusion criteria.
  8. Patients who are unable to provide written informed consent
  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: NCT01295840

Locations
Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Dr. Francisco Javier Alzueta Rodríguez, PhD Hospital Clínico Universitario Virgen de la Victoria
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01295840     History of Changes
Other Study ID Numbers: CR 10-046-SP-HF
Study First Received: February 3, 2011
Results First Received: June 6, 2014
Last Updated: March 5, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

ClinicalTrials.gov processed this record on July 28, 2015