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QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead (QUARTO-II)

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ClinicalTrials.gov Identifier: NCT01733368
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
Optimization and evolution of the patient will be evaluated over 6 months after the implant.

Condition or disease
Heart Failure

Detailed Description:
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.

Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Study Start Date : November 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2016



Primary Outcome Measures :
  1. Number of Responder Patients (Structural Remodelling) [ Time Frame: 6 months after implant ]
    Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.

  2. Safety Outcomes in CRT Responders and Non-Responders [ Time Frame: 6 months after implant ]
    • Mortality rate,
    • Rate of cardiovascular hospitalizations and for any cause or
    • Combined endpoint (death and all-cause hospitalization)


Secondary Outcome Measures :
  1. Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector [ Time Frame: 6 months after implant ]

    Response is defined as a reduction >15% in LVESV, measured 6 months after implant.

    Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads.


  2. Number of Responder Patients With Conventional Left Ventricular Pacing Vector [ Time Frame: 6 months after implant ]

    Response is defined as a reduction >15% in LVESV, measured 6 months after implant.

    Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart failure patients
Criteria

Inclusion Criteria:

  • Patient with implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle.
  • Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured
  • Patients who have granted their informed consent.
  • Patients above 18 years.

Exclusion Criteria:

  • Patients that have been previously resynchronized.
  • Patients with aortic stenosis or aortic valve prosthesis
  • Patients who are or may potentially be pregnant.
  • Patients with a life expectancy <12 months.
  • Patients who cannot attend the monitoring visits established by the protocol.

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 ClinicalTrials.gov identifier (NCT number): NCT01733368


Locations
Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Javier Alzueta, MD Hospital Clínico Universitario Virgen de la Victoria

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01733368     History of Changes
Other Study ID Numbers: CR-1 2-015-SP-HF
First Posted: November 27, 2012    Key Record Dates
Results First Posted: March 1, 2018
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan

Keywords provided by St. Jude Medical:
CRT
Optimization
Responders

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases