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: June 4, 2013
Last verified: June 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • The percentage of patients whose cardiac output 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) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    The clinical response will be assessed on the basis of the change in each patient's cardiac output using the different stimulation configurations offered by the Quartet® electrode in comparison with conventional stimulation with a bipolar left ventricular electrode (with the reference configurations LV (Left ventricle) tip-LV Ring, LV Tip-RV Coil, LV Ring-RV Coil) as well as the baseline values, in other words without stimulation.


Secondary Outcome Measures:
  • Width of the QRS. [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    The width of the QRS complex will be measured and its correlation with each patient's cardiac output will be determined for each of the different stimulation configurations used.

  • Presence of mitral regurgitation. [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    The presence of mitral regurgitation will be assessed echocardiographically for each of the configurations used. Correlation with other parameters will be evaluated.

  • The optimization AV and VV delay values. [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]

    The optimization AV and VV delay values used for each of the configurations studied will be noted.

    Attempts will be made to determine the optimal stimulation configuration for each patient's hemodynamics using the measurements undertaken.


  • Capture and phrenic threshold. [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ 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.


  • The final position of the electrode. [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    Information regarding the final position of the electrode and its relationship with the other parameters evaluated, namely electrical measurements of the capture and phrenic thresholds, QRS width and cardiac output and mitral regurgitation values, will also be collected.

  • Final stimulation vector programmed. [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    Information regarding the final stimulation vector program selected by the physician for patients with a Quartet® lead implanted in the left ventricle will also be collected.

  • CO improvement at 6 month follow up visit [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    Information regarding the percentage of patients whose cardiac output improves after six months, and their correlation with the values obtained at the initial visit. Correlation with other parameters measured will be evaluated.

  • Echocardiographic measurements (volumes, diameters and EF) and response at 6 month [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    Information regarding the volumes, diameters and EF at 6 month follow up visit and their correlation with the values obtained at the initial visit. Correlation with other parameters will be evaluated.

  • Myocardial Performance Index (MPI) [ Time Frame: Enrollment visit (in the seven days after implantation of the device) and 6 month post-implant visit. ] [ Designated as safety issue: No ]
    The MPI will be assessed echocardiographically for each of the configurations used. Correlation with other parameters will be evaluated.


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 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 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
Last Updated: June 4, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 30, 2014