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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00990665
Recruitment Status : Completed
First Posted : October 7, 2009
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Device: CRT-D and LV lead (Quartet™ lead and Promote Q® device system) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Freedom From Left Ventricular Lead-Related Complications Through 3 Months [ Time Frame: 3 months ]
    The primary safety endpoint for this study is freedom from left ventricular lead-related complications through 3 months.

  2. Freedom From System-related Complications Through 3 Months [ Time Frame: 3 Months ]
    The co-primary safety endpoint for this study is freedom from system-related complications through 3 months.

  3. The Primary Effectiveness Endpoint for the Promote Q System Was the Responder Rate to Biventricular Pacing at 3 Months. [ Time Frame: 3 Months ]
    The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at 3 months. A responder per protocol was defined as a patient with an LV pacing threshold of <2.5 V at 0.5ms in the D1-M2 pacing configuration (Vector 1) AND at least one other non-standard programmable biventricular lead vector. Non-standard vectors included Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2) and Vector 10 (P4-RV coil).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00990665


  Show 24 Study Locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Gery Tomassoni, MD Central Baptist Hospital

Publications of Results:
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00990665     History of Changes
Other Study ID Numbers: 60024498/E
First Posted: October 7, 2009    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Abbott Medical Devices:
CRT
Heart Failure
LV Leads
Additional relevant MeSH terms:
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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