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
  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:


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
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: 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
Ethinyl estradiol, levonorgestrel drug combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014