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Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00990665
First received: October 6, 2009
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and Promote Q® device system in a patient population indicated for cardiac resynchronization therapy.


Condition Intervention
Heart Failure
 Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary and Co-Primary Safety Endpoints of the Promote Q® device system will be evaluated through 3 months. The responder rate of biventricular pacing at 3 months will be reported. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 178
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CRT-D and LV lead Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Promote Q CRT-D and Quartet LV lead

  Eligibility

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

Inclusion Criteria:

  • Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
  • Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
  • Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations

Exclusion Criteria:

  • Have had a recent CVA or TIA within three months of enrollment
  • Have a contraindication for an emergency thoracotomy
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
  • Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
  • Have undergone a cardiac transplantation within 40 days of enrollment
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
  • Are currently participating in a clinical investigation that includes an active treatment arm
  • Are pregnant or planning to become pregnant during the duration of the study
  • Have a life expectancy of less than 6 months due to any condition
  • Are less than 18 years of age
  • Are unable to comply with the follow up schedule
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990665

  Show 24 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Gery Tomassoni, MD Central Baptist Hospital
  More Information

Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00990665     History of Changes
Other Study ID Numbers: 60024498/E
Study First Received: October 6, 2009
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
CRT
Heart Failure
LV Leads

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013