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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

October 2, 2012
November 27, 2012
May 31, 2017
March 1, 2018
March 1, 2018
November 2012
August 2015   (Final data collection date for primary outcome measure)
  • 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.
  • 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)
Optimization method [ Time Frame: From implant procedure until 6 months post-implant ]
Optimization method. The primary endpoint of this study is to evaluate the usual management (according to the different methods of optimisation used) of patients undergoing Cardiac Resynchronization Therapy (CRT), that have a QuartetTM quadripolar lead with a CRT-D Device implanted during the 6 months post-implant. Information about the optimization method used, parameters and variables used with them and number of optimization during 6months post-implant will be collected.
Complete list of historical versions of study NCT01733368 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Safety [ Time Frame: From implant procedure until 6 months post-implant ]
    Number of patients with device-related adverse events as a measure of safety, deaths, cardiovascular hospitalizations and hospitalisations for any reason, assessed up to 6 months post-implant.
  • Percentage of responder patients (structural remodelling) [ Time Frame: 6 months after implant ]
    Structural remodelling is defined as a reduction >15% in End Systolic Volume of the Left Ventricle (LVESV), measured 6months after implant.
  • Demographic data [ Time Frame: Up to 10 days post-implant ]
    Collect demographic information (gender, age, height, weight), medical and cardiovascular history.
  • Treated TV/FV episodes incidence [ Time Frame: From implant procedure until 6 months post-implant ]
    Number of treated TV/FV episodes over the 6 months post-implant
Not Provided
Not Provided
 
QUARTO-II Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Heart failure patients
Heart Failure
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
200
August 2016
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01733368
CR-1 2-015-SP-HF
No
Not Provided
Plan to Share IPD: No
Plan Description: No plan
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Javier Alzueta, MD Hospital Clínico Universitario Virgen de la Victoria
St. Jude Medical
February 2018