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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01733368
First received: October 2, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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


Condition
Heart Failure

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Optimization method [ Time Frame: From implant procedure until 6 months post-implant ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Safety [ Time Frame: From implant procedure until 6 months post-implant ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of treated TV/FV episodes over the 6 months post-implant


Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT01733368

Contacts
Contact: Elena Llorente +34917278940 ellorente@sjm.com
Contact: Antonio Ruiz +347278928 aruiz@sjm.com

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01733368     History of Changes
Other Study ID Numbers: CR-1 2-015-SP-HF
Study First Received: October 2, 2012
Last Updated: November 20, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by St. Jude Medical:
CRT
Optimization
Responders

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014